A Prospective, Randomized Comparison of Graft Patency and Clinical Outcomes After Coronary Bypass Surgery Performed With and Without the Use of Cardiopulmonary Bypass:Longitudinal Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- after > 5 years, graft patency determined by non-invasive dual 64 slice multi-detector computed tomographic coronary angiography and cardiac positron emission tomography.
研究概览
简要总结
The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at > 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery.
详细描述
The Surgical Management of Arterial Revascularization Therapies (SMART) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 unselected patients referred for elective, isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass. These patients were enrolled between March 2000 to August 2001.
The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass (OPCAB)are no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass (CABG/CPB)after > 5 years of follow-up (non-inferiority hypothesis).
The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at > 5 years:
- Neurocognitive Function
- Stroke/cerebral injury
- Health-related quality of life
- Myocardial perfusion and ischemia
- Major Adverse Cardiac Events (MACE)
- Cardiac Functional Status
- Incidence and severity of angina
- All cause mortality and cardiovascular mortality
- Cost of hospital re-admissions since 1 year follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial
排除标准
- •Emergent CABG
- •Required pre-operative intra-aortic balloon pump (IABP)
- •Cardiogenic shock
- •Evolving acute myocardial infarction
- •Coronary artery targets unsuitable for off-pump bypass surgery
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
after > 5 years, graft patency determined by non-invasive dual 64 slice multi-detector computed tomographic coronary angiography and cardiac positron emission tomography.
时间窗: 8 year follow-up
次要结局
- Secondary outcomes will be measured by; a battery of neuropsychological tests, MRI, NIH stroke scale, questionnaires, cardiac PET scanning, NYHA and CCS classifications and Medicare DRG's.(8 year follow-up)