xml: <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/NCT06036901</url>
    </required_header>
    <id_info>
      <org_study_id>CardioVascularRF</org_study_id>
      <nct_id>NCT06036901</nct_id>
    </id_info>
    <brief_title>Asan Medical Center CCTA Registry</brief_title>
    <official_title>Assessment of Coronary Artery Disease in Asymptomatic Population Undergoing Coronary Computed Tomography Angiography: A Single Center, Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CardioVascular Research Foundation, Korea</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CardioVascular Research Foundation, Korea</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>
        A total of 9269 adults who received CCTA scans for coronary disease evaluation during a&#xD;
        general medical checkup at the Health Screening and Promotion Center in Asan Medical Center,&#xD;
        Seoul, Korea between January 2007 and December 2011 were initially selected. All participants&#xD;
        were provided with information about the potential benefits and risks of CCTA and made the&#xD;
        decision to undergo the procedure at their own expense. They were also informed that their&#xD;
        clinical and radiological data would be used for this study and gave their consent. Of these&#xD;
        individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2007</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">December 31, 2011</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>10 Years</target_duration>
    <primary_outcome>
      <measure>The prevalence of CAD</measure>
      <time_frame>5 years</time_frame>
      <description>Diameter stenosis &gt;50% in any coronary artery by coronary CT angiography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>All cause mortality</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cardiovascular mortality</measure>
      <time_frame>5 years</time_frame>
      <description>any death caused by a cardiovascular problem or if there was no identified cause of death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>myocardial infarction</measure>
      <time_frame>5 years</time_frame>
      <description>Number of participants with an increase in cardiac enzyme above the upper reference limit with ischemic symptoms or signs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revascularization</measure>
      <time_frame>5 years</time_frame>
      <description>Number of participants with any percutaneous or surgical revascularization procedure during follow-up.</description>
    </secondary_outcome>
    <enrollment type="Actual">6343</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Risk Factor</condition>
    <condition>Computed Tomography</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Coronary CT</intervention_name>
      <description>Coronary CT evaluation</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals aged 20 years and older had undergone self-referral CCTA evaluation as part of&#xD;
          a general health examination in the Health Screening and Promotion Center at Asan Medical&#xD;
          Center from January 2007 to December 2011.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Exclusion Criteria:&#xD;
  &#xD;
            1. a previous history of angina or myocardial infarction;&#xD;
  &#xD;
            2. abnormal rest electrocardiographic results, i.e., pathological Qwaves, ischemic ST&#xD;
               segments or T wave changes, or left bundle-branch blocks;&#xD;
  &#xD;
            3. insufficient medical records;&#xD;
  &#xD;
            4. structural heart diseases;&#xD;
  &#xD;
            5. a prior history of open heart surgery or percutaneous coronary intervention;&#xD;
  &#xD;
            6. a previous cardiac procedure; or&#xD;
  &#xD;
            7. renal insufficiency (creatinine N1.5 mg/dL)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>CardioVascular Research Foundation, Korea</investigator_affiliation>
      <investigator_full_name>Seung-Whan Lee</investigator_full_name>
      <investigator_title>Principal investigator, clinical professor</investigator_title>
    </responsible_party>
    <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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036901
  org study id: CardioVascularRF
  nct id: NCT06036901
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A total of 9269 adults who received CCTA scans for coronary disease evaluation during a
        general medical checkup at the Health Screening and Promotion Center in Asan Medical Center,
        Seoul, Korea between January 2007 and December 2011 were initially selected. All participants
        were provided with information about the potential benefits and risks of CCTA and made the
        decision to undergo the procedure at their own expense. They were also informed that their
        clinical and radiological data would be used for this study and gave their consent. Of these
        individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.
  observational model: Cohort
  time perspective: Prospective
  measure: The prevalence of CAD
  time frame: 5 years
  description: Diameter stenosis >50% in any coronary artery by coronary CT angiography
  measure: All cause mortality
  time frame: 5 years
  measure: cardiovascular mortality
  time frame: 5 years
  description: any death caused by a cardiovascular problem or if there was no identified cause of death
  measure: myocardial infarction
  time frame: 5 years
  description: Number of participants with an increase in cardiac enzyme above the upper reference limit with ischemic symptoms or signs.
  measure: Revascularization
  time frame: 5 years
  description: Number of participants with any percutaneous or surgical revascularization procedure during follow-up.
  intervention type: Diagnostic Test
  intervention name: Coronary CT
  description: Coronary CT evaluation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: CardioVascular Research Foundation, Korea
  investigator full name: Seung-Whan Lee
  investigator title: Principal investigator, clinical professor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: No