Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
研究概览
简要总结
The purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts.
详细描述
The issue of whether to perform conventional CABG or off-pump CABG continues to be the subject of debate. Controversy remains regarding the appropriateness of applying OPCAB to all patients as opposed to selected sub-populations.
The main strategy of CABG is to obtain complete revascularization with the least morbidity and highest long-term patency rates. Current medical literature is conflicted regarding graft patency rates in OPCAB vs. conventional CABG. Data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. Cardiac computed tomography (CT) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. This study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump CABG using cardiac CT scanning. The study hypothesis is that graft patency rates will be equivalent between the two techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •Surgery indicated
- •Patient is hemodynamically stable
- •Isolated coronary artery surgery (no valve)
- •No contraindications to cardiopulmonary bypass
- •No previous surgery (not redo CABG)
排除标准
- •critically ill patient with hemodynamic instability.
- •concomitant cardiac procedures.
- •inability to provide written informed consent.
- •prior severe reaction to contrast dye :
- •life-threatening anaphylactoid reactions
- •cardiac dysrhythmias and arrest
- •cardiovascular and pulmonary collapse
- •elevated serum creatinine (>150 mmol/L).
- •contraindications to cardiopulmonary bypass.
- •Age < 18 years .
结局指标
主要结局
Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
次要结局
- Post-op Complications
- Length of Hospital Stay
- Operative Time
- Blood Loss
- Quality of Life Assessment