<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/NCT03263806</url>
  </required_header>
  <id_info>
    <org_study_id>2017-272</org_study_id>
    <nct_id>NCT03263806</nct_id>
  </id_info>
  <brief_title>The Computed Tomography-derived Fractional Flow Reserve STAT Trial</brief_title>
  <acronym>CTFFR-STAT</acronym>
  <official_title>Computed Tomography-derived Fractional Flow Reserve in the Systematic Triage of Emergency Department Acute Chest Pain Patients to Treatment. (The CTFFR-STAT Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to directly compare Standard Care and CT fractional flow reserve&#xD;
      (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on&#xD;
      heart computed tomography (CT) scans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      New or worsening chest discomfort is the most common symptom of coronary artery disease&#xD;
      (CAD), which is plaque build-up in the arteries that supply the heart muscle with blood.&#xD;
      Chest pain is one of the most common reasons for emergency department (ED) visits, with an&#xD;
      estimated 8 million new cases every year. Evaluation of chest pain is expensive and time&#xD;
      consuming, even though 75% of the time it is not due to CAD. It is necessary to carefully&#xD;
      define the amount of CAD, even if initial tests reveal no heart attack, because this symptom&#xD;
      may progress to heart attack and death if missed.&#xD;
&#xD;
      Coronary artery computed tomography angiography of the heart (CCTA) is one of the most&#xD;
      sensitive tests to detect serious CAD in appropriately selected patients.In 85% of acute&#xD;
      chest pain (ACP) ED cases tested by CCTA, no CAD or very mild CAD is found, leading to rapid&#xD;
      discharge or an alternative diagnosis. However, in the 15% of patients with significant CAD&#xD;
      found on CCTA, further evaluation with either stress testing or heart catheterization, and/or&#xD;
      hospital admission is required. Since 2015, Beaumont Health hospitals have employed a new&#xD;
      FDA-approved test, called CT fractional flow reserve (CTFFR), that can analyze flow down the&#xD;
      heart arteries by computer analysis of the original CT images. Results from an analysis of&#xD;
      147 patients suggest that 67% of the time, CTFFR showed no significant flow limitation,&#xD;
      providing for the potential to defer invasive testing or treatment for a trial of medical&#xD;
      therapy.&#xD;
&#xD;
      The use of CTFFR on ED patients is novel, and it is not yet part of the standard of care&#xD;
      (SOC). Standard care of patients with definite CAD on CCTA continues to be hospital&#xD;
      admission, stress testing and/or heart catheterization for further diagnosis. Both CTFFR and&#xD;
      standard care continue to be used at Beaumont Health, and it is important to determine if one&#xD;
      or the other diagnostic strategy is superior. This study is designed to directly compare&#xD;
      standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on&#xD;
      CCTA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">April 4, 2018</completion_date>
  <primary_completion_date type="Actual">April 4, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Catheterization Rate</measure>
    <time_frame>3 months after initial presentation</time_frame>
    <description>Percent of patients undergoing heart catheterization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Effectiveness</measure>
    <time_frame>3 months after initial presentation</time_frame>
    <description>Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Major Adverse Cardiac Events</measure>
    <time_frame>1 year after presentation</time_frame>
    <description>Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>An average of 2 days</time_frame>
    <description>Time from admission to discharge from hospital in days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Heart Disease, Coronary</condition>
  <condition>Chest Pain</condition>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>SOC Group Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTFFR-Guided Group Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CTFFR-Guided Group Management</intervention_name>
    <description>Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</description>
    <arm_group_label>CTFFR-Guided Group Management</arm_group_label>
    <other_name>Computed tomography - fractional flow reserve</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SOC Group Management</intervention_name>
    <description>Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
    <arm_group_label>SOC Group Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency department chest pain suspicious for ACS based on history and physical&#xD;
             examination.&#xD;
&#xD;
          -  At least one biomarker (troponin) and electrocardiogram with no evidence of definite&#xD;
             ACS.&#xD;
&#xD;
          -  A completed CCTA demonstrating &gt;50% but &lt;90% stenosis of at least one coronary artery&#xD;
             branch.&#xD;
&#xD;
          -  CCTA test images with sufficient diagnostic quality for CTFFR analysis.&#xD;
&#xD;
          -  Ability and willingness to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left main coronary stenosis of 50% or greater.&#xD;
&#xD;
          -  CCTA lesions demonstrating stenosis &gt;90% (&quot;subtotal&quot;), or complex, high-risk plaque&#xD;
             characteristics resulting in an a priori recommendation for triage to CATH by the CCTA&#xD;
             interpreting physician.&#xD;
&#xD;
          -  Attending physician a priori decision for CATH.&#xD;
&#xD;
          -  Previous coronary stent, coronary bypass or prior known myocardial infarction.&#xD;
&#xD;
          -  Clinical instability, such as hypotension, signs of shock, and/or accelerating chest&#xD;
             pain requiring admission.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilbert Raff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Health System - Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>April 30, 2018</results_first_submitted>
  <results_first_submitted_qc>June 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2018</results_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Gilbert L. Raff, MD</investigator_full_name>
    <investigator_title>Director Cardiac MRI/CT</investigator_title>
  </responsible_party>
  <keyword>angina</keyword>
  <keyword>coronary artery disease</keyword>
  <keyword>coronary artery catheterization</keyword>
  <keyword>coronary CT angiography</keyword>
  <keyword>fractional flow reserve CT</keyword>
  <keyword>emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>January 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03263806/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Emergency department patients who had a Cardiac CT scan, were screened for the study. The doctors interpreting the CT scan notifies the research coordinator regarding potential eligibility of the patient to the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>SOC Group Management</title>
          <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
        </group>
        <group group_id="P2">
          <title>CTFFR-Guided Group Management</title>
          <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Study Terminated due to lack of enrollment</participants>
                <participants group_id="P2" count="0">Study Terminated due to lack of enrollment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Elevated Troponin (failed screen)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled patients less 1 withdrawal in CTFFR guided group management and 1 patient removed for elevated troponin in SOC group management.</population>
      <group_list>
        <group group_id="B1">
          <title>SOC Group Management</title>
          <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
        </group>
        <group group_id="B2">
          <title>CTFFR-Guided Group Management</title>
          <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</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="5"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="43" upper_limit="76"/>
                    <measurement group_id="B2" value="60.5" lower_limit="47" upper_limit="75"/>
                    <measurement group_id="B3" value="57" lower_limit="43" upper_limit="76"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Catheterization Rate</title>
        <description>Percent of patients undergoing heart catheterization</description>
        <time_frame>3 months after initial presentation</time_frame>
        <population>Study terminated with NO data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>SOC Group Management</title>
            <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
          </group>
          <group group_id="O2">
            <title>CTFFR-Guided Group Management</title>
            <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</description>
          </group>
        </group_list>
        <measure>
          <title>Catheterization Rate</title>
          <description>Percent of patients undergoing heart catheterization</description>
          <population>Study terminated with NO data collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diagnostic Effectiveness</title>
        <description>Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy</description>
        <time_frame>3 months after initial presentation</time_frame>
        <population>Study terminated with NO data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>SOC Group Management</title>
            <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
          </group>
          <group group_id="O2">
            <title>CTFFR-Guided Group Management</title>
            <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Effectiveness</title>
          <description>Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy</description>
          <population>Study terminated with NO data collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Major Adverse Cardiac Events</title>
        <description>Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization</description>
        <time_frame>1 year after presentation</time_frame>
        <population>Study terminated with NO data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>SOC Group Management</title>
            <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
          </group>
          <group group_id="O2">
            <title>CTFFR-Guided Group Management</title>
            <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Major Adverse Cardiac Events</title>
          <description>Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization</description>
          <population>Study terminated with NO data collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Time from admission to discharge from hospital in days</description>
        <time_frame>An average of 2 days</time_frame>
        <population>Study terminated with NO data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>SOC Group Management</title>
            <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
          </group>
          <group group_id="O2">
            <title>CTFFR-Guided Group Management</title>
            <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Time from admission to discharge from hospital in days</description>
          <population>Study terminated with NO data collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SOC Group Management</title>
          <description>Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.&#xD;
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment</description>
        </group>
        <group group_id="E2">
          <title>CTFFR-Guided Group Management</title>
          <description>Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.&#xD;
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Study terminated early due to difficulty of enrollment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Korana Stakich-Alpirez</name_or_title>
      <organization>Beaumont Hospitals</organization>
      <phone>248 898 0315</phone>
      <email>Korana.Stakich-Alpirez@beaumont.org</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/NCT03263806
org study id: 2017-272
nct id: NCT03263806
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is designed to directly compare Standard Care and CT fractional flow reserve
      (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on
      heart computed tomography (CT) scans.
New or worsening chest discomfort is the most common symptom of coronary artery disease
      (CAD), which is plaque build-up in the arteries that supply the heart muscle with blood.
      Chest pain is one of the most common reasons for emergency department (ED) visits, with an
      estimated 8 million new cases every year. Evaluation of chest pain is expensive and time
      consuming, even though 75% of the time it is not due to CAD. It is necessary to carefully
      define the amount of CAD, even if initial tests reveal no heart attack, because this symptom
      may progress to heart attack and death if missed.

      Coronary artery computed tomography angiography of the heart (CCTA) is one of the most
      sensitive tests to detect serious CAD in appropriately selected patients.In 85% of acute
      chest pain (ACP) ED cases tested by CCTA, no CAD or very mild CAD is found, leading to rapid
      discharge or an alternative diagnosis. However, in the 15% of patients with significant CAD
      found on CCTA, further evaluation with either stress testing or heart catheterization, and/or
      hospital admission is required. Since 2015, Beaumont Health hospitals have employed a new
      FDA-approved test, called CT fractional flow reserve (CTFFR), that can analyze flow down the
      heart arteries by computer analysis of the original CT images. Results from an analysis of
      147 patients suggest that 67% of the time, CTFFR showed no significant flow limitation,
      providing for the potential to defer invasive testing or treatment for a trial of medical
      therapy.

      The use of CTFFR on ED patients is novel, and it is not yet part of the standard of care
      (SOC). Standard care of patients with definite CAD on CCTA continues to be hospital
      admission, stress testing and/or heart catheterization for further diagnosis. Both CTFFR and
      standard care continue to be used at Beaumont Health, and it is important to determine if one
      or the other diagnostic strategy is superior. This study is designed to directly compare
      standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on
      CCTA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Catheterization Rate
time frame: 3 months after initial presentation
description: Percent of patients undergoing heart catheterization
measure: Diagnostic Effectiveness
time frame: 3 months after initial presentation
description: Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
measure: Incidence of Major Adverse Cardiac Events
time frame: 1 year after presentation
description: Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
measure: Hospital Length of Stay
time frame: An average of 2 days
description: Time from admission to discharge from hospital in days
arm group label: SOC Group Management
arm group type: Active Comparator
description: Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.
arm group label: CTFFR-Guided Group Management
arm group type: Experimental
description: Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.
intervention type: Diagnostic Test
intervention name: CTFFR-Guided Group Management
description: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
arm group label: CTFFR-Guided Group Management
other name: Computed tomography - fractional flow reserve
intervention type: Diagnostic Test
intervention name: SOC Group Management
description: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
arm group label: SOC Group Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilbert Raff, MD
role: Principal Investigator
affiliation: Beaumont Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Gilbert L. Raff, MD
investigator title: Director Cardiac MRI/CT
mesh term: Heart Diseases
mesh term: Acute Coronary Syndrome
mesh term: Coronary Disease
mesh term: Chest Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study terminated early due to difficulty of enrollment.
point of contact: 