Back to resultsCABG Based on CT-FFR Versus Conventional Coronary Angiography
Primary Purpose
Coronary Artery Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronary artery bypass grafting based on conventional coronary angiography
Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: age equal or more than 40 age equal or less than 75 patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease patients who agree to the enrollment Exclusion Criteria: Patients with heart failure (left ventricular ejection fraction < 25%) patients who have intractable ventricular arrhythmia patients who has been treated for cancer patients who has infectious disease patients who are planned to undergo combined cardiac surgery patients who has medical co-morbidity with expected survival less than 1 year patients with a history of previous cardiac surgery Patients with chronic renal failure requiring dialysis patients who undergo emergency operation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CAG group
CT-FFR group
Arm Description
Patients who underwent coronary artery bypass grafting based on conventional coronary angiography
Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve
Outcomes
Primary Outcome Measures
1-Year graft patency rates
postoperative graft patency measured by 1 year postoperative coronary angiography
Secondary Outcome Measures
Overall survival
Overall survival rate at 4 years
Freedom from Cardiac Death
Freedom from cardiac death at 4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Early Angiographic Patency Rates
The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06028165
Brief Title
CABG Based on CT-FFR Versus Conventional Coronary Angiography
Official Title
A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Myongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAG group
Arm Type
Active Comparator
Arm Description
Patients who underwent coronary artery bypass grafting based on conventional coronary angiography
Arm Title
CT-FFR group
Arm Type
Active Comparator
Arm Description
Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting based on conventional coronary angiography
Intervention Description
Revascularized coronary arteries are decided based on conventional coronary angiography.
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
Intervention Description
Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.
Primary Outcome Measure Information:
Title
1-Year graft patency rates
Description
postoperative graft patency measured by 1 year postoperative coronary angiography
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival rate at 4 years
Time Frame
4 years
Title
Freedom from Cardiac Death
Description
Freedom from cardiac death at 4 years
Time Frame
4 years
Title
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
Description
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Time Frame
4 years
Title
Early Angiographic Patency Rates
Description
The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting
Time Frame
1.5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age equal or more than 40
age equal or less than 75
patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease
patients who agree to the enrollment
Exclusion Criteria:
Patients with heart failure (left ventricular ejection fraction < 25%)
patients who have intractable ventricular arrhythmia
patients who has been treated for cancer
patients who has infectious disease
patients who are planned to undergo combined cardiac surgery
patients who has medical co-morbidity with expected survival less than 1 year
patients with a history of previous cardiac surgery
Patients with chronic renal failure requiring dialysis
patients who undergo emergency operation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Seok Kim, MD, PhD, MSc
Phone
82-10-8482-0380
Email
minseok.kim.md.phd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Seok Kim, MD, PhD, MSc
Organizational Affiliation
Cardiovascular Center, Myongji Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.
Learn more about this trial
CABG Based on CT-FFR Versus Conventional Coronary Angiography
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