CABG Based on CT-FFR Versus Conventional Coronary Angiography

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary artery bypass grafting based on conventional coronary angiography
* Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAG group<br>Patients who underwent coronary artery bypass grafting based on conventional coronary angiography | Procedure: Coronary artery bypass grafting based on conventional coronary angiography<br>* Revascularized coronary arteries are decided based on conventional coronary angiography.<br>|
| Active Comparator: CT-FFR group<br>Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve | Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.<br>* Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-Year graft patency rates | postoperative graft patency measured by 1 year postoperative coronary angiography | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival rate at 4 years | 4 years | 
| Freedom from Cardiac Death | Freedom from cardiac death at 4 years | 4 years | 
| Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years | 4 years | 
| Early Angiographic Patency Rates | The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting | 1.5 days |