<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/NCT03253692</url>
  </required_header>
  <id_info>
    <org_study_id>170146</org_study_id>
    <secondary_id>17-H-0146</secondary_id>
    <nct_id>NCT03253692</nct_id>
  </id_info>
  <brief_title>Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)</brief_title>
  <official_title>Prospective Multicenter Registry On Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed&#xD;
      tomography angiography. It uses scanning to look at the arteries that supply blood to the&#xD;
      heart. It is noninvasive, widely available, and generally accurate. But it does expose people&#xD;
      to radiation. Exposure to high amounts of radiation can increase a person s risk of getting&#xD;
      cancer. Researchers want to learn more about the relationship between CCTA and radiation&#xD;
      exposure.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To see how much radiation is used to take pictures of the heart and how measures to reduce&#xD;
      radiation are used around the world.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 18 years and older who need a computed tomography (CT) scan of the heart&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with a review of their medical records.&#xD;
&#xD;
      Participants may have a pregnancy test.&#xD;
&#xD;
      Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A&#xD;
      small tube will be placed into a vein in the arm. A contrast material (dye) will be given&#xD;
      through it. Participants will lie on the CT scanning table.&#xD;
&#xD;
      A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac CT angiography is a commonly used test to take detailed pictures of the heart to&#xD;
      diagnose heart disease; however, it is associated with radiation exposure. Several&#xD;
      technological advances in both scanner hardware and software are now available to reduce the&#xD;
      radiation exposure to patients. The purpose of this study is to evaluate the worldwide usage&#xD;
      of these radiation dose saving strategies in daily practice and analyze their effect on image&#xD;
      quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">October 11, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine radiation dose estimates of cardiac CT angiographies in daily practice</measure>
    <time_frame>day 0</time_frame>
    <description>We will assess the variation of radiation dose with respect to vendors, CT systems and study sites. Furthermore, we will evaluate the usage of dose saving strategies including the abovementionedin daily practice and analyze their effect on diagnostic image quality. On the basis of the collected data, we will evaluate the potential use of additional dose savings for each individual site.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <condition>Arterial Occlusive Diseases</condition>
  <condition>Arteriosclerosis</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>People ages 18 years and older who need a computed tomography (CT) scan of the heart.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Data confirming the inclusion/exclusion criteria will be confirmed at the study visit.&#xD;
        Overall, up to 100 subjects will be enrolled locally at the NIH. A member of the study team&#xD;
        will review the CT procedures and confirm that the participants do not have any serious&#xD;
        health problems or concomitant conditions or medications that would prevent them from&#xD;
        having the CT. A member of the study team will perform a pregnancy test (if applicable) in&#xD;
        female participants of childbearing potential. If you are nursing, you will be excluded&#xD;
        from this study. All tests will follow NIH Clinical Center policies and clinical consent&#xD;
        forms for individual tests may be obtained in addition to the study protocol consent as&#xD;
        applicable. Sites outside the NIH will use similar standard of care procedures for cardiac&#xD;
        CT eligibility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Clinical indication for cardiac CT angiography to evaluate coronary arteries or&#xD;
                  other cardiac structures&#xD;
&#xD;
               2. Age equal to or greater than 18 years&#xD;
&#xD;
               3. Able to understand and willing to sign the Informed Consent Form&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        1) Female participants who are pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Y Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart, Lung, and Blood Institute (NHLBI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-H-0146.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>February 24, 2023</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Computed Tomography</keyword>
  <keyword>Radiation</keyword>
  <keyword>Iterative Reconstruction</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03253692
org study id: 170146
secondary id: 17-H-0146
nct id: NCT03253692
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed
      tomography angiography. It uses scanning to look at the arteries that supply blood to the
      heart. It is noninvasive, widely available, and generally accurate. But it does expose people
      to radiation. Exposure to high amounts of radiation can increase a person s risk of getting
      cancer. Researchers want to learn more about the relationship between CCTA and radiation
      exposure.

      Objective:

      To see how much radiation is used to take pictures of the heart and how measures to reduce
      radiation are used around the world.

      Eligibility:

      People ages 18 years and older who need a computed tomography (CT) scan of the heart

      Design:

      Participants will be screened with a review of their medical records.

      Participants may have a pregnancy test.

      Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A
      small tube will be placed into a vein in the arm. A contrast material (dye) will be given
      through it. Participants will lie on the CT scanning table.

      A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.
Cardiac CT angiography is a commonly used test to take detailed pictures of the heart to
      diagnose heart disease; however, it is associated with radiation exposure. Several
      technological advances in both scanner hardware and software are now available to reduce the
      radiation exposure to patients. The purpose of this study is to evaluate the worldwide usage
      of these radiation dose saving strategies in daily practice and analyze their effect on image
      quality.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Determine radiation dose estimates of cardiac CT angiographies in daily practice
time frame: day 0
description: We will assess the variation of radiation dose with respect to vendors, CT systems and study sites. Furthermore, we will evaluate the usage of dose saving strategies including the abovementionedin daily practice and analyze their effect on diagnostic image quality. On the basis of the collected data, we will evaluate the potential use of additional dose savings for each individual site.
arm group label: Patients
description: People ages 18 years and older who need a computed tomography (CT) scan of the heart.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Marcus Y Chen, M.D.
role: Principal Investigator
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
facility: 
country: United States
country: Canada
country: Germany
country: Israel
country: United Kingdom
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-H-0146.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Arteriosclerosis
mesh term: Arterial Occlusive Diseases
mesh term: Ischemia
sharing ipd: Undecided