CABG Based on CT-FFR Versus Conventional Coronary Angiography

Sponsor
Myongji Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06028165
Collaborator
(none)
80
2
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Coronary artery bypass grafting based on conventional coronary angiography
  • Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
N/A

Detailed Description

The CABG-COREA trial is designed as a randomized, controlled trial to recruit 80 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CAG group

Patients who underwent coronary artery bypass grafting based on conventional coronary angiography

Procedure: Coronary artery bypass grafting based on conventional coronary angiography
Revascularized coronary arteries are decided based on conventional coronary angiography.

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.

Outcome Measures

Primary Outcome Measures

  1. 1-Year graft patency rates [1 year]

    postoperative graft patency measured by 1 year postoperative coronary angiography

Secondary Outcome Measures

  1. Overall survival [4 years]

    Overall survival rate at 4 years

  2. Freedom from Cardiac Death [4 years]

    Freedom from cardiac death at 4 years

  3. Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) [4 years]

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

  4. Early Angiographic Patency Rates [1.5 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age equal or more than 40

  • age equal or less than 75

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Myongji Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min-Seok Kim, Associate Professor, Myongji Hospital
ClinicalTrials.gov Identifier:
NCT06028165
Other Study ID Numbers:
  • MyongjiH
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023