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/NCT06028165</url>
    </required_header>
    <id_info>
      <org_study_id>MyongjiH</org_study_id>
      <nct_id>NCT06028165</nct_id>
    </id_info>
    <brief_title>CABG Based on CT-FFR Versus Conventional Coronary Angiography</brief_title>
    <official_title>A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Myongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Myongji Hospital</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>
        The aims of study are (1) to compare early and 1-year graft patency rates in patients who&#xD;
        underwent coronary artery bypass grafting (CABG) based on conventional coronary&#xD;
        angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR),&#xD;
        and (2) to demonstrate difference in clinical outcomes between the 2 groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The CABG-COREA trial is designed as a randomized, controlled trial to recruit 80 patients who&#xD;
        undergo coronary artery bypass grafting. Patients were randomized by use of a randomization&#xD;
        table. Coronary arteries are revascularized based on conventional coronary angiography or&#xD;
        cardiac computed tomography-derived fractional flow reserve according to the randomization&#xD;
        result.&#xD;
  &#xD;
        The primary end point is to evaluate early and 1-year postoperative graft patency. The&#xD;
        secondary end points are overall survival, freedom from cardiac death and freedom from&#xD;
        MACCE(major adverse cardiac or cerebrovascular events).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>1-Year graft patency rates</measure>
      <time_frame>1 year</time_frame>
      <description>postoperative graft patency measured by 1 year postoperative coronary angiography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>4 years</time_frame>
      <description>Overall survival rate at 4 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Freedom from Cardiac Death</measure>
      <time_frame>4 years</time_frame>
      <description>Freedom from cardiac death at 4 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)</measure>
      <time_frame>4 years</time_frame>
      <description>freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early Angiographic Patency Rates</measure>
      <time_frame>1.5 days</time_frame>
      <description>The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>CAG group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who underwent coronary artery bypass grafting based on conventional coronary angiography</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CT-FFR group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Coronary artery bypass grafting based on conventional coronary angiography</intervention_name>
      <description>Revascularized coronary arteries are decided based on conventional coronary angiography.</description>
      <arm_group_label>CAG group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.</intervention_name>
      <description>Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.</description>
      <arm_group_label>CT-FFR group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age equal or more than 40&#xD;
  &#xD;
            -  age equal or less than 75&#xD;
  &#xD;
            -  patients who undergo coronary artery bypass grafting due to multi-vessel coronary&#xD;
               artery disease&#xD;
  &#xD;
            -  patients who agree to the enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with heart failure (left ventricular ejection fraction &lt; 25%)&#xD;
  &#xD;
            -  patients who have intractable ventricular arrhythmia&#xD;
  &#xD;
            -  patients who has been treated for cancer&#xD;
  &#xD;
            -  patients who has infectious disease&#xD;
  &#xD;
            -  patients who are planned to undergo combined cardiac surgery&#xD;
  &#xD;
            -  patients who has medical co-morbidity with expected survival less than 1 year&#xD;
  &#xD;
            -  patients with a history of previous cardiac surgery&#xD;
  &#xD;
            -  Patients with chronic renal failure requiring dialysis&#xD;
  &#xD;
            -  patients who undergo emergency operation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Min-Seok Kim, MD, PhD, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>Cardiovascular Center, Myongji Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Min-Seok Kim, MD, PhD, MSc</last_name>
      <phone>82-10-8482-0380</phone>
      <email>minseok.kim.md.phd@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Myongji Hospital</investigator_affiliation>
      <investigator_full_name>Min-Seok Kim</investigator_full_name>
      <investigator_title>Associate 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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>It is not yet known if there will be a plan to make IPD available.</ipd_description>
    </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/NCT06028165
  org study id: MyongjiH
  nct id: NCT06028165
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aims of study are (1) to compare early and 1-year graft patency rates in patients who
        underwent coronary artery bypass grafting (CABG) based on conventional coronary
        angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR),
        and (2) to demonstrate difference in clinical outcomes between the 2 groups.
  The CABG-COREA trial is designed as a randomized, controlled trial to recruit 80 patients who
        undergo coronary artery bypass grafting. Patients were randomized by use of a randomization
        table. Coronary arteries are revascularized based on conventional coronary angiography or
        cardiac computed tomography-derived fractional flow reserve according to the randomization
        result.
  
        The primary end point is to evaluate early and 1-year postoperative graft patency. The
        secondary end points are overall survival, freedom from cardiac death and freedom from
        MACCE(major adverse cardiac or cerebrovascular events).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: 1-Year graft patency rates
  time frame: 1 year
  description: postoperative graft patency measured by 1 year postoperative coronary angiography
  measure: Overall survival
  time frame: 4 years
  description: Overall survival rate at 4 years
  measure: Freedom from Cardiac Death
  time frame: 4 years
  description: Freedom from cardiac death at 4 years
  measure: Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
  time frame: 4 years
  description: freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
  measure: Early Angiographic Patency Rates
  time frame: 1.5 days
  description: The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting
  arm group label: CAG group
  arm group type: Active Comparator
  description: Patients who underwent coronary artery bypass grafting based on conventional coronary angiography
  arm group label: CT-FFR group
  arm group type: Active Comparator
  description: Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve
  intervention type: Procedure
  intervention name: Coronary artery bypass grafting based on conventional coronary angiography
  description: Revascularized coronary arteries are decided based on conventional coronary angiography.
  arm group label: CAG group
  intervention type: Procedure
  intervention name: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
  description: Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.
  arm group label: CT-FFR group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Min-Seok Kim, MD, PhD, MSc
  role: Study Chair
  affiliation: Cardiovascular Center, Myongji Hospital
  last name: Min-Seok Kim, MD, PhD, MSc
  phone: 82-10-8482-0380
  email: minseok.kim.md.phd@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Myongji Hospital
  investigator full name: Min-Seok Kim
  investigator title: Associate Professor
  mesh term: Coronary Artery Disease
  sharing ipd: Undecided
  ipd description: It is not yet known if there will be a plan to make IPD available.