CABG Based on CT-FFR Versus Conventional Coronary Angiography

Myongji Hospital96 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Coronary artery bypass grafting based on conventional coronary angiographyPROCEDURE

Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)

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

Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

1-Year graft patency rates

postoperative graft patency measured by 1 year postoperative coronary angiography

Time frame: 1 year

Secondary Outcomes

Overall survival

Overall survival rate at 4 years

Time frame: 4 years

Freedom from Cardiac Death

Freedom from cardiac death at 4 years

Time frame: 4 years

Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years

Time frame: 4 years

Early Angiographic Patency Rates

The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting

Time frame: 1.5 days

Central Contacts

Min-Seok Kim, MD, PhD, MSc

CONTACT

82-10-8482-0380 minseok.kim.md.phd@gmail.com

Data from ClinicalTrials.gov

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