<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/NCT01680081</url>
  </required_header>
  <id_info>
    <org_study_id>1-2011-0064</org_study_id>
    <nct_id>NCT01680081</nct_id>
  </id_info>
  <brief_title>Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed as a prospective multicenter trial to determine the accuracy of&#xD;
      combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic&#xD;
      perfusion imaging in patients with suspicious coronary artery disease compared conventional&#xD;
      coronary angiography and quantitative dynamic perfusion MRI as standard reference.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment of target subjects and difficulty registering subjects&#xD;
  </why_stopped>
  <start_date type="Actual">January 30, 2012</start_date>
  <completion_date type="Actual">July 11, 2016</completion_date>
  <primary_completion_date type="Actual">July 11, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of stress induced CT perfusion</measure>
    <time_frame>10-30 days</time_frame>
    <description>Diagnostic accuracy of combined stress and rest dynamic CT perfusion and coronary angiography with dual x-ray sources in detection of hemodynamically significant stenosis of coronary artery compared with conventional coronary angiography and perfusion MRI in patients with suspicious coronary artery disease.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>CT perfusion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adenosine stress dynamic CT perfusion</intervention_name>
    <arm_group_label>CT perfusion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women patients, with age ranging 40-80.&#xD;
&#xD;
          2. Suspected coronary artery disease who are supposed to undergo invasive coronary&#xD;
             angiography with appropriate clinical indications&#xD;
&#xD;
          3. Patients who are willing to sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication of CT Known allergy to iodinated contrast media or history of&#xD;
             contrast-induced nephropathy Decreased renal function: elevated serum&#xD;
             creatinine(&gt;1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial&#xD;
             fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block&#xD;
             (second or third degree heart block)&#xD;
&#xD;
          2. Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR&lt;30&#xD;
             ml/min&#xD;
&#xD;
          3. Unstable or uncooperative patients&#xD;
&#xD;
          4. Limited life expectancy due to cancer or end-stage renal or liver disease&#xD;
&#xD;
          5. Evidence of severe symptomatic heart failure (NYHA Class III or IV)&#xD;
&#xD;
          6. Previous myocardial infarction, coronary artery intervention, coronary artery bypass&#xD;
             surgery, or other cardiac surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenosine</mesh_term>
  </intervention_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/NCT01680081
org study id: 1-2011-0064
nct id: NCT01680081
lead sponsor: 
has dmc: No
This study was designed as a prospective multicenter trial to determine the accuracy of
      combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic
      perfusion imaging in patients with suspicious coronary artery disease compared conventional
      coronary angiography and quantitative dynamic perfusion MRI as standard reference.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic accuracy of stress induced CT perfusion
time frame: 10-30 days
description: Diagnostic accuracy of combined stress and rest dynamic CT perfusion and coronary angiography with dual x-ray sources in detection of hemodynamically significant stenosis of coronary artery compared with conventional coronary angiography and perfusion MRI in patients with suspicious coronary artery disease.
arm group label: CT perfusion group
arm group type: Experimental
intervention type: Other
intervention name: Adenosine stress dynamic CT perfusion
arm group label: CT perfusion group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Adenosine