Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Per patient bypass graft failure (defined as ≥75% graft diameter stenosis) in at least one bypass graft, as assessed by quantitative coronary angiography performed at 12 months.
研究概览
简要总结
Aortocoronary bypass graft failure is common and is associated with high morbidity and mortality. Failure of saphenous vein grafts is more common than failure of internal mammary artery grafts. Whether early graft angiography can reduce bypass graft failure remains unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO) randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to early (before dismissal) graft angiography vs. no early graft angiography. Coronary angiography will be performed at 12 months, to determine whether compared to no early graft angiography, early graft angiography will result in:
- lower per patient angiographic bypass graft failure (in at least one graft) rates (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy endpoint)
- lower per graft failure rates, per graft occlusion rates, and per patient bypass graft occlusion rates (in at least one bypass graft) (secondary endpoints)
- lower incidence major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) (secondary endpoint)
Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at least one bypass graft at baseline (in the early graft angiography group only) and at 12-month angiographic follow-up to evaluate the structural bypass graft changes occurring after coronary artery bypass graft surgery (secondary endpoint).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- •Undergoing clinically-indicated coronary artery bypass graft surgery
排除标准
- •Positive pregnancy test or breast-feeding
- •Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
- •Serum creatinine > 2.5 mg/dL or acute renal failure
- •Severe peripheral arterial disease limiting vascular access
研究组 & 干预措施
Early graft angiography after coronary artery bypass surgery
Treatment of any bypass graft abnormalities that are discovered will be performed if needed
干预措施: bypass graft angiography (Procedure)
No early angiography after coronary artery bypass surgery
结局指标
主要结局
Per patient bypass graft failure (defined as ≥75% graft diameter stenosis) in at least one bypass graft, as assessed by quantitative coronary angiography performed at 12 months.
时间窗: 12 months
次要结局
- Major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction)(12 months)
- Per graft incidence of bypass graft failure; per graft incidence of bypass graft occlusion; and per patient incidence of at least one bypass graft occlusion(12 months)
- Mean SVG lumen diameter and wall thickness, as assessed by intravascular ultrasonography and mean lipid core burden index, as assessed by near-infrared intracoronary spectroscopy(12 months)
研究者
Emmanouil Brilakis
Director, Cardiac Catheterization Laboratories
North Texas Veterans Healthcare System