CABG Based on CT-FFR Versus Conventional Coronary Angiography

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028165
• Other study ID #: MyongjiH
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2024
• Source: Myongji Hospital
• Contact: Min-Seok Kim, MD, PhD, MSc
• Phone: 82-10-8482-0380
• Email: minseok.kim.md.phd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Coronary artery bypass grafting based on conventional coronary angiography
Revascularized coronary arteries are decided based on conventional coronary angiography.
• Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.

Locations

Country	Name	City	State
Korea, Republic of	Myongji Hospital	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Myongji Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-Year graft patency rates	postoperative graft patency measured by 1 year postoperative coronary angiography	1 year
Secondary	Overall survival	Overall survival rate at 4 years	4 years
Secondary	Freedom from Cardiac Death	Freedom from cardiac death at 4 years	4 years
Secondary	Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)	freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years	4 years
Secondary	Early Angiographic Patency Rates	The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting	1.5 days