Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- cognitive decline 5 year after the index treatment
研究概览
简要总结
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of the heart lung machine. We hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine. The objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome, five years after surgery.
详细描述
Background:
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of cardiopulmonary bypass (CPB). A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24% at six months after surgery, but it increased to 42% at five years. In the recently conducted Octopus Randomized Trial, cognitive decline at three months after surgery was present in 29% of the patients operated with CPB. In the patients operated without CPB, the incidence was 21%, i.e. only slightly better.
Hypothesis:
Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery.
Study objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
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
- •indication for (first-time) coronary artery bypass surgery
- •off-pump CABG considered technically possible
排除标准
- •concomitant valve surgery
- •unable to complete neuropsychological testing
- •life expectancy less than 1 year
结局指标
主要结局
cognitive decline 5 year after the index treatment
次要结局
- -freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA
- -recurrence of angina
- -use of anti-anginal drugs
- -quality of life (SF-36 and EuroQuol