Coronary Artery Disease
Conditions
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.
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).
Interventions
PROCEDURECoronary artery bypass grafting based on conventional coronary angiography
Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)
PROCEDURECoronary 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.
Sponsors
Myongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Year graft patency rates | 1 year | postoperative graft patency measured by 1 year postoperative coronary angiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 4 years | Overall survival rate at 4 years |
| Freedom from Cardiac Death | 4 years | Freedom from cardiac death at 4 years |
| Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | 4 years | freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years |
| Early Angiographic Patency Rates | 1.5 days | The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting |
Countries
South Korea
Contacts
Primary ContactMin-Seok Kim, MD, PhD, MSc
Outcome results
None listed