Graft Imaging to Improve Patency (GRIIP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Graft occlusion determined by conventional angiography or CT angiography
研究概览
简要总结
The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis (>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment. Patency will be assessed with a new fluorescence angiography technique as well as ultrasonic transit-time flow measurement. We hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We also hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of 50-99% stenoses at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We expect both groups will experience similar perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative patency assessment and graft revision will experience improved long-term graft patency and freedom from late clinical events at 5-6 years post-operatively.
详细描述
The immediate and long term success of coronary surgery is dependent on the construction of a high quality anastomosis with a durable conduit to an appropriate target coronary vessel. Significant advances in medical therapy including early post-operative aspirin administration and increased use of arterial grafting have improved early, midterm and late graft patency. However, modern coronary bypass series continue to report perioperative graft occlusions rates as high as 11%. These very early graft failures have been predominantly ascribed to technical problems at graft anastomosis sites and may be preventable. New intraoperative graft assessment technologies have recently become available which can identify technical problems such that they can be repaired in the operating room. However, these techniques increase the length of the bypass operation and may have false positives, which may lead to unnecessary and potentially damaging graft revisions. The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis(>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated aortocoronary bypass surgery
- •left ventricular ejection fraction >20%
- •expect at least 2 bypass grafts
排除标准
- •renal insufficiency (creatinine >180 umol/L)
- •known allergy to indocyanine green contrast dye
- •severe peripheral vascular disease precluding femoral access
- •known allergy to radiographic contrast media
- •women of childbearing potential
- •co-morbid illness which precludes the use of follow-up angiography
- •geographically inaccessible for follow-up angiography
结局指标
主要结局
Graft occlusion determined by conventional angiography or CT angiography
时间窗: 4 days to 4 months following surgery
次要结局
- Mortality, myocardial infarction, low output syndrome(Perioperatively)
- Major cardiac adverse events(1 year postoperatively)
- 50-99% graft stenosis on postoperative graft angiography(4 day to 4 months postoperatively)
研究者
Stephen E. Fremes
Head , Division of Cardiac Surgery
Sunnybrook Health Sciences Centre
