NCT01834846Unknown不适用
Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Graft function
研究概览
简要总结
The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.
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
- Single (Outcomes Assessor)
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
- •Isolated elective, primary CABG requiring cardiopulmonary bypass
- •Left ventricular ejection fraction >35%
- •at least one saphenous vein graft required as part of revascularization strategy
排除标准
- •Acute or chronic inflammatory diseases
- •Malignancies
- •Pregnancy
- •Previous cardiac surgery
- •Serum creatinine >120 μmol/L
- •Coagulopathy
- •Insulin dependent diabetes mellitus
- •Smoking during last 6 months
- •Leg not suitable for No-touch vein harvesting as judged by the operator.
- •Need for nitrates on operation day
- •not receiving statins
研究组 & 干预措施
no-touch
Experimental
no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting
干预措施: no-touch (Procedure)
conventional
Active Comparator
conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting
干预措施: conventional (Procedure)
结局指标
主要结局
Graft function
时间窗: 5 years
Graft function as evaluated by coronary angiography in all 100 patients
Graft function
时间窗: 6 months
Graft function as evaluated by coronary angiography in the first 60 out of 100 patients
次要结局
- Morphological appearance of vein graft(5 years)
- Postoperative leg wound complications(6 weeks)
- Postoperative complications related to cardiac surgery(5 years)
- Morphological appearance of vein graft(6 months)
- Postoperative complications related to cardiac surgery(Discharge, 6 weeks, 6 months)
研究者
研究点 (1)
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