CABG Based on CT-FFR Versus Conventional Coronary Angiography

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min-Seok Kim, MD, PhD, MSc; Phone Number: 82-10-8482-0380; Email: minseok.kim.md.phd@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Myongji Hospital
      • Contact: Min-Seok Kim, MD, PhD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)	freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years	4 years
Overall survival	Overall survival rate at 4 years	4 years
Freedom from Cardiac Death	Freedom from cardiac death 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

Collaborators and Investigators

• Sponsor: Myongji Hospital
• Investigators: Study Chair: Min-Seok Kim, MD, PhD, MSc, Cardiovascular Center, Myongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MyongjiH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No