<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/NCT01696006</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV 2012-04</org_study_id>
    <nct_id>NCT01696006</nct_id>
  </id_info>
  <brief_title>Perfusion CT Registry</brief_title>
  <acronym>Perfusion CT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Young-Hak Kim, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether coronary perfusion computed tomography is&#xD;
      effective in the treatment of coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2013</start_date>
  <completion_date type="Actual">January 14, 2021</completion_date>
  <primary_completion_date type="Actual">November 25, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of coronary perfusion computed tomography</measure>
    <time_frame>5year</time_frame>
    <description>Positive predictive value Negative predictive value Sensitivity Specificity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between coronary perfusion computed tomography and fraction flow reserve</measure>
    <time_frame>5year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between coronary perfusion computed tomography and SPECT(nuclear imaging)</measure>
    <time_frame>5year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>occurrence of the event after coronary perfusion computed tomography</measure>
    <time_frame>5year</time_frame>
    <description>Death Myocardial infarction coronary angiography Revascularization</description>
  </secondary_outcome>
  <enrollment type="Actual">1059</enrollment>
  <condition>Coronary Artery Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        General hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age greater than or equal to 20&#xD;
&#xD;
          -  Patient who has a coronary perfusion computed tomography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness or inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-Gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soonchunhyang university hospital</name>
      <address>
        <city>Bucheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A university hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Daejeon ST. Mary's Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ChonBuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje university Pusan Paik hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Young-Hak Kim, MD, PhD</investigator_full_name>
    <investigator_title>Young-Hak Kim, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>perfusion computed tomography</keyword>
  <keyword>coronary artery disease</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>
  </condition_browse>
  <!-- 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/NCT01696006
org study id: AMCCV 2012-04
nct id: NCT01696006
lead sponsor: 
The purpose of this study is to determine whether coronary perfusion computed tomography is
      effective in the treatment of coronary artery disease.
observational model: Case-Only
time perspective: Prospective
measure: Accuracy of coronary perfusion computed tomography
time frame: 5year
description: Positive predictive value Negative predictive value Sensitivity Specificity
measure: Relationship between coronary perfusion computed tomography and fraction flow reserve
time frame: 5year
measure: Relationship between coronary perfusion computed tomography and SPECT(nuclear imaging)
time frame: 5year
measure: occurrence of the event after coronary perfusion computed tomography
time frame: 5year
description: Death Myocardial infarction coronary angiography Revascularization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Young-Hak Kim, MD, PhD
investigator title: Young-Hak Kim, MD, PhD
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease