<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972242</url>
  </required_header>
  <id_info>
    <org_study_id>396906</org_study_id>
    <nct_id>NCT02972242</nct_id>
  </id_info>
  <brief_title>Focused Field of View Calcium Scoring Prior to Coronary CT Angiography</brief_title>
  <acronym>FOCUS-CCTA</acronym>
  <official_title>Focused Field of View Calcium Scoring Prior to Coronary CT Angiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walter Reed National Military Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary computed tomography angiography (CCTA) is a frequently performed test for the&#xD;
      diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected&#xD;
      patients. The performance of non-contrast computed tomography for the detection and&#xD;
      quantification of coronary calcification is typically performed prior to CCTA in an effort to&#xD;
      identify significant calcification which may influence subsequent data acquisition during the&#xD;
      CCTA. However, performance of calcium scoring adds significant radiation and most coronary&#xD;
      calcification is proximal in its location, potentially visualized using a focused&#xD;
      non-contrast scan.&#xD;
&#xD;
      The purpose of this study is to prospectively compare the usefulness of a modified&#xD;
      non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as&#xD;
      compared to standard coronary artery calcium scanning for the detection of coronary&#xD;
      calcification that may influence subsequent CCTA performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to undergoing CCTA, non-contrast CT scanning of the entire heart is usually performed&#xD;
      in adults over 50-years of age in order to assess for the presence and severity of coronary&#xD;
      artery calcium. By providing a modified CT scan with a reduced length the same data can be&#xD;
      obtained by the imager to ensure a high quality scan while decreasing the patient's overall&#xD;
      radiation exposure. Our objectives and specific aims to validate our hypothesis include:&#xD;
&#xD;
        -  To assess the impact on CCTA image quality using modified calcium score approach&#xD;
&#xD;
        -  To determine the rate of changes in the coronary CT angiography acquisition parameters&#xD;
           after evaluation of the modified versus standard calcium scoring scout series.&#xD;
           Significant changes in CCTA acquisition include any of the following as compared to&#xD;
           recommended CCTA parameters prior to scout CT performance: a change (increase or&#xD;
           decrease) in tube current (mA) by 50, any change in tube potential (kV), change to/from&#xD;
           retrospectively-gated CCTA, any change in padding (acquisition window), or changing&#xD;
           to/from a high definition CT scan acquisition.&#xD;
&#xD;
        -  To assess the difference in patient estimated effective radiation exposure (mSv) between&#xD;
           the modified versus standard calcium scoring techniques.&#xD;
&#xD;
        -  To assess the difference in patient estimated effective radiation exposure (mSv) of the&#xD;
           entire CCTA study (plus calcium scoring) between groups.&#xD;
&#xD;
      Study Design Prospective, randomized single-center cohort study.&#xD;
&#xD;
      Anticipated Requirements&#xD;
&#xD;
        1. Facilities: Walter Reed National Military Medical Center&#xD;
&#xD;
             1. Cardiology Clinic&#xD;
&#xD;
             2. Cardiovascular Health and Interventional Radiology, Angiography and Recovery&#xD;
                [CVHIR]&#xD;
&#xD;
             3. Radiology Department (CT Section)&#xD;
&#xD;
        2. Duration of enrollment: 12 months&#xD;
&#xD;
        3. Budget: no additional budget is needed.&#xD;
&#xD;
      Subject Population&#xD;
&#xD;
        1. One hundred seventy-five (175) male and female adult subjects (military health&#xD;
           beneficiaries age greater than 50 years) who are clinically referred for CCTA will be&#xD;
           eligible for participation.&#xD;
&#xD;
        2. The Walter Reed National Military Medical Center Cardiology Department and Radiology&#xD;
           Departments perform multiple clinically appropriate and indicated coronary CTA studies&#xD;
           weekly (approximately 8-12), which will allow for ease of subject recruitment. Although&#xD;
           there are other open studies using CCTA in our department there is not a lot of overlap&#xD;
           in their requirements and should not prohibit enrollment in our study. This study will&#xD;
           enroll both men and women of all ethnic origins aged ≥ 50 years. All subjects will&#xD;
           consent for themselves. All patients' participation in this research and subsequent&#xD;
           contribution to our medical knowledge notwithstanding, no intent to benefit patients&#xD;
           from enrollment is implied or offered. Pregnant women will be excluded from enrollment&#xD;
           based on:&#xD;
&#xD;
             1. Verbal admission of pregnant status; OR&#xD;
&#xD;
             2. Positive urine pregnancy test performed within 7 days of CCTA in subjects not&#xD;
                previously known to be pregnant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative Quality Comparison</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale).&#xD;
= Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast.&#xD;
= Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis.&#xD;
= Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque.&#xD;
= Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative Quality Comparison</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio):&#xD;
image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA &quot;signal&quot; and standard deviation of the HU within that same region (which is the &quot;noise&quot;), the ratio of these signal/noise is also captured by this method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Coronary CT Parameter Changes (mA by 50).</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in a change in milliamps by 50.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Coronary CT Parameter Changes (Tube Potential).</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring (i.e. increasing or decreasing the tube potential)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Coronary CT Using High Definition Scanning.</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>Any use of of the &quot;high definition&quot; scanning parameter after evaluation of the calcium burden by modified or standard calcium scoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in any changes in padding (milliseconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison Radiation Exposure in Non-Con CT (Dose Length Product)</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>The measurement of radiation exposure as DLP (measured in mSv/mGycm) in comparison of the modified versus standard calcium scoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>The measurement of radiation exposure difference measured as DLP/milli-sieverts of the entire CCTA study on the modified versus standard calcium scoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants for Which There Was a Scan Termination Event</measure>
    <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
    <description>Number of patients whose coronary CTA scan was canceled by the imaging provider due to extreme levels of calcium noted during the modified or standard calcium scoring scan.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Radiation Safety</condition>
  <condition>Coronary Computed Tomography Angiography</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Modified Field of View</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Field of View</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Field of View</intervention_name>
    <description>Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
    <arm_group_label>Modified Field of View</arm_group_label>
    <arm_group_label>Standard Field of View</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Consenting adult patients ≥ 50 years of age;&#xD;
&#xD;
          2. Suspected but without known prior history of CAD. Prior CAD is defined as a history of&#xD;
             myocardial infarction, coronary revascularization or ≥ 50% coronary lumen stenosis on&#xD;
             prior coronary angiography&#xD;
&#xD;
          3. Scheduled for non-emergent clinically indicated coronary CT angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior coronary bypass graft (CABG) surgery&#xD;
&#xD;
          2. Suspicion of acute coronary syndrome (MI or unstable angina)&#xD;
&#xD;
          3. Known complex congenital heart disease&#xD;
&#xD;
          4. Evidence of ongoing or active clinical instability, including chest pain (sudden&#xD;
             onset); cardiogenic shock; unstable blood pressure with systolic blood pressure &lt; 90&#xD;
             mmHg; and severe congestive heart failure (NYHA class III or IV); or acute pulmonary&#xD;
             embolism&#xD;
&#xD;
          5. Atrial fibrillation&#xD;
&#xD;
          6. Abnormal renal function (GFR &lt; 60 ml/min; Creatinine &gt; 1.5 mg/dL)&#xD;
&#xD;
          7. Concomitant participation in another clinical trial in which patient is subject to&#xD;
             investigation drug or device&#xD;
&#xD;
          8. Pregnancy or unknown pregnancy status&#xD;
&#xD;
          9. Allergy to iodinated contrast agent&#xD;
&#xD;
         10. Contraindications to nitroglycerin&#xD;
&#xD;
         11. Unwilling or unable to give consent&#xD;
&#xD;
         12. Inability to comply with study procedures&#xD;
&#xD;
         13. Prior coronary artery calcium score and/or coronary CT angiogram&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hampton A Crimm, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>WRNMMC Cardiology Department</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>October 1, 2019</results_first_submitted>
  <results_first_submitted_qc>June 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2020</results_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Walter Reed National Military Medical Center</investigator_affiliation>
    <investigator_full_name>Hampton Crimm</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 14, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02972242/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Modified Field of View</title>
          <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
        </group>
        <group group_id="P2">
          <title>Standard Field of View</title>
          <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>82 patients were enrolled to the Modified group. As previously mentioned, one withdrew consent immediately after randomization (i.e. prior to undergoing scan). Two additional scans within the modified group were unavailable to the PI at the time of data analysis (i.e. years after the scan, due to data migration failure)</population>
      <group_list>
        <group group_id="B1">
          <title>Modified Field of View</title>
          <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
        </group>
        <group group_id="B2">
          <title>Standard Field of View</title>
          <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="172"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" spread="5.8"/>
                    <measurement group_id="B2" value="59" spread="7.3"/>
                    <measurement group_id="B3" value="58" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Qualitative Quality Comparison</title>
        <description>The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale).&#xD;
= Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast.&#xD;
= Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis.&#xD;
= Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque.&#xD;
= Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <population>Within the modified group: 1 patient had previously withdrawn consent and 2 additional scans were subsequently unavailable for review at the time of measurement of the outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Quality Comparison</title>
          <description>The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale).&#xD;
= Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast.&#xD;
= Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis.&#xD;
= Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque.&#xD;
= Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.</description>
          <population>Within the modified group: 1 patient had previously withdrawn consent and 2 additional scans were subsequently unavailable for review at the time of measurement of the outcomes.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quantitative Quality Comparison</title>
        <description>The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio):&#xD;
image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA &quot;signal&quot; and standard deviation of the HU within that same region (which is the &quot;noise&quot;), the ratio of these signal/noise is also captured by this method.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Quality Comparison</title>
          <description>The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio):&#xD;
image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA &quot;signal&quot; and standard deviation of the HU within that same region (which is the &quot;noise&quot;), the ratio of these signal/noise is also captured by this method.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="6.1"/>
                    <measurement group_id="O2" value="17.9" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Coronary CT Parameter Changes (mA by 50).</title>
        <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in a change in milliamps by 50.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Coronary CT Parameter Changes (mA by 50).</title>
          <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in a change in milliamps by 50.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Coronary CT Parameter Changes (Tube Potential).</title>
        <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring (i.e. increasing or decreasing the tube potential)</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Coronary CT Parameter Changes (Tube Potential).</title>
          <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring (i.e. increasing or decreasing the tube potential)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Coronary CT Using High Definition Scanning.</title>
        <description>Any use of of the &quot;high definition&quot; scanning parameter after evaluation of the calcium burden by modified or standard calcium scoring.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Coronary CT Using High Definition Scanning.</title>
          <description>Any use of of the &quot;high definition&quot; scanning parameter after evaluation of the calcium burden by modified or standard calcium scoring.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).</title>
        <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in any changes in padding (milliseconds).</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).</title>
          <description>Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in any changes in padding (milliseconds).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison Radiation Exposure in Non-Con CT (Dose Length Product)</title>
        <description>The measurement of radiation exposure as DLP (measured in mSv/mGycm) in comparison of the modified versus standard calcium scoring.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison Radiation Exposure in Non-Con CT (Dose Length Product)</title>
          <description>The measurement of radiation exposure as DLP (measured in mSv/mGycm) in comparison of the modified versus standard calcium scoring.</description>
          <units>mSv/mGycm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="6"/>
                    <measurement group_id="O2" value="53" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)</title>
        <description>The measurement of radiation exposure difference measured as DLP/milli-sieverts of the entire CCTA study on the modified versus standard calcium scoring.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)</title>
          <description>The measurement of radiation exposure difference measured as DLP/milli-sieverts of the entire CCTA study on the modified versus standard calcium scoring.</description>
          <units>mSv/mGycm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240" spread="137"/>
                    <measurement group_id="O2" value="295" spread="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants for Which There Was a Scan Termination Event</title>
        <description>Number of patients whose coronary CTA scan was canceled by the imaging provider due to extreme levels of calcium noted during the modified or standard calcium scoring scan.</description>
        <time_frame>Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Modified Field of View</title>
            <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>Standard Field of View</title>
            <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants for Which There Was a Scan Termination Event</title>
          <description>Number of patients whose coronary CTA scan was canceled by the imaging provider due to extreme levels of calcium noted during the modified or standard calcium scoring scan.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Modified Field of View</title>
          <description>In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
        </group>
        <group group_id="E2">
          <title>Standard Field of View</title>
          <description>In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.&#xD;
Field of View: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="82"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>single center design and relatively small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Hampton Crimm</name_or_title>
      <organization>WRNMMC Cardiology</organization>
      <phone>301-295-4500</phone>
      <email>hampton.a.crimm.mil@mail.mil</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972242
org study id: 396906
nct id: NCT02972242
lead sponsor: 
has dmc: No
Coronary computed tomography angiography (CCTA) is a frequently performed test for the
      diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected
      patients. The performance of non-contrast computed tomography for the detection and
      quantification of coronary calcification is typically performed prior to CCTA in an effort to
      identify significant calcification which may influence subsequent data acquisition during the
      CCTA. However, performance of calcium scoring adds significant radiation and most coronary
      calcification is proximal in its location, potentially visualized using a focused
      non-contrast scan.

      The purpose of this study is to prospectively compare the usefulness of a modified
      non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as
      compared to standard coronary artery calcium scanning for the detection of coronary
      calcification that may influence subsequent CCTA performance.
Prior to undergoing CCTA, non-contrast CT scanning of the entire heart is usually performed
      in adults over 50-years of age in order to assess for the presence and severity of coronary
      artery calcium. By providing a modified CT scan with a reduced length the same data can be
      obtained by the imager to ensure a high quality scan while decreasing the patient's overall
      radiation exposure. Our objectives and specific aims to validate our hypothesis include:

        -  To assess the impact on CCTA image quality using modified calcium score approach

        -  To determine the rate of changes in the coronary CT angiography acquisition parameters
           after evaluation of the modified versus standard calcium scoring scout series.
           Significant changes in CCTA acquisition include any of the following as compared to
           recommended CCTA parameters prior to scout CT performance: a change (increase or
           decrease) in tube current (mA) by 50, any change in tube potential (kV), change to/from
           retrospectively-gated CCTA, any change in padding (acquisition window), or changing
           to/from a high definition CT scan acquisition.

        -  To assess the difference in patient estimated effective radiation exposure (mSv) between
           the modified versus standard calcium scoring techniques.

        -  To assess the difference in patient estimated effective radiation exposure (mSv) of the
           entire CCTA study (plus calcium scoring) between groups.

      Study Design Prospective, randomized single-center cohort study.

      Anticipated Requirements

        1. Facilities: Walter Reed National Military Medical Center

             1. Cardiology Clinic

             2. Cardiovascular Health and Interventional Radiology, Angiography and Recovery
                [CVHIR]

             3. Radiology Department (CT Section)

        2. Duration of enrollment: 12 months

        3. Budget: no additional budget is needed.

      Subject Population

        1. One hundred seventy-five (175) male and female adult subjects (military health
           beneficiaries age greater than 50 years) who are clinically referred for CCTA will be
           eligible for participation.

        2. The Walter Reed National Military Medical Center Cardiology Department and Radiology
           Departments perform multiple clinically appropriate and indicated coronary CTA studies
           weekly (approximately 8-12), which will allow for ease of subject recruitment. Although
           there are other open studies using CCTA in our department there is not a lot of overlap
           in their requirements and should not prohibit enrollment in our study. This study will
           enroll both men and women of all ethnic origins aged ≥ 50 years. All subjects will
           consent for themselves. All patients' participation in this research and subsequent
           contribution to our medical knowledge notwithstanding, no intent to benefit patients
           from enrollment is implied or offered. Pregnant women will be excluded from enrollment
           based on:

             1. Verbal admission of pregnant status; OR

             2. Positive urine pregnancy test performed within 7 days of CCTA in subjects not
                previously known to be pregnant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Qualitative Quality Comparison
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale).
= Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast.
= Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis.
= Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque.
= Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.
measure: Quantitative Quality Comparison
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio):
image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA "signal" and standard deviation of the HU within that same region (which is the "noise"), the ratio of these signal/noise is also captured by this method.
measure: Number of Patients With Coronary CT Parameter Changes (mA by 50).
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in a change in milliamps by 50.
measure: Number of Patients With Coronary CT Parameter Changes (Tube Potential).
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring (i.e. increasing or decreasing the tube potential)
measure: Number of Patients With Coronary CT Using High Definition Scanning.
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: Any use of of the "high definition" scanning parameter after evaluation of the calcium burden by modified or standard calcium scoring.
measure: Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in any changes in padding (milliseconds).
measure: Comparison Radiation Exposure in Non-Con CT (Dose Length Product)
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: The measurement of radiation exposure as DLP (measured in mSv/mGycm) in comparison of the modified versus standard calcium scoring.
measure: Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: The measurement of radiation exposure difference measured as DLP/milli-sieverts of the entire CCTA study on the modified versus standard calcium scoring.
measure: Number of Participants for Which There Was a Scan Termination Event
time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
description: Number of patients whose coronary CTA scan was canceled by the imaging provider due to extreme levels of calcium noted during the modified or standard calcium scoring scan.
arm group label: Modified Field of View
arm group type: Active Comparator
description: In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
arm group label: Standard Field of View
arm group type: Placebo Comparator
description: In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.
intervention type: Radiation
intervention name: Field of View
description: Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
arm group label: Modified Field of View
arm group label: Standard Field of View
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Hampton A Crimm, MD
role: Principal Investigator
affiliation: WRNMMC Cardiology Department
responsible party type: Principal Investigator
investigator affiliation: Walter Reed National Military Medical Center
investigator full name: Hampton Crimm
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: single center design and relatively small sample size.
point of contact: 