CABG Based on CT-FFR Versus Conventional Coronary Angiography

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary artery bypass grafting based on conventional coronary angiography; Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.

• Registration Number: NCT06028165
• Lead Sponsor: Myongji Hospital

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 96 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 (quantitative 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).

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-08
• Study Start: 2023-10-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• age equal or more than 40
• age equal or less than 80
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAG group	Coronary artery bypass grafting based on conventional coronary angiography	Patients who underwent coronary artery bypass grafting based on conventional coronary angiography (quantitative coronary angiography)
CT-FFR group	Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.	Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve

Primary Outcome Measures

Name	Time	Method
1-Year graft patency rates	1 year	postoperative graft patency measured by 1 year postoperative coronary angiography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Myongji Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of