CABG Based on CT-FFR Versus Conventional Coronary Angiography

Myongji Hospital

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary artery bypass grafting based on conventional coronary angiography; Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.

Study type: Interventional

Funder types: Other

Identifiers

NCT06028165

MyongjiH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 96 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

CAG group

Active Comparator group

Description:

Patients who underwent coronary artery bypass grafting based on conventional coronary angiography (quantitative coronary angiography)

Treatment:

Procedure: Coronary artery bypass grafting based on conventional coronary angiography

CT-FFR group

Active Comparator group

Description:

Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve

Treatment:

Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.