A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- 1-Year graft patency rates
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
1-Year graft patency rates
时间窗: 1 year
postoperative graft patency measured by 1 year postoperative coronary angiography
次要结局
- Early Angiographic Patency Rates(1.5 days)
- Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)(4 years)
- Overall survival(4 years)
- Freedom from Cardiac Death(4 years)
研究者
Min-Seok Kim
Associate Professor
Myongji Hospital