Hybrid Coronary Revascularization Versus Coronary Artery Bypass Surgery for Treatment of Multivessel Coronary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
研究概览
简要总结
The purpose of the study is to find out if hybrid coronary revascularization (HCR) and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.
详细描述
Currently, it is not clear how the outcomes of hybrid coronary revascularization (HCR) compare with other treatments. The purpose of the study is to find out if HCR and coronary artery bypass grafting (CABG) procedure outcomes are similar. HCR is a combination of surgery and catheter procedures to open up clogged heart arteries. CABG is a surgical procedure to open up clogged heart arteries.
This study will collect information about the medical care participants receive during their planned procedure. No new testing or procedures will be done. Participants will have only the tests or procedures already planned by their doctor. The investigators will look at how well participants do after the procedure by assessing the outcomes of interest 30 days after surgery and, potentially, one year after surgery (funding dependent).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent
- •Have multi-vessel coronary artery disease (CAD) involving the Left Anterior Descending (LAD) artery
- •Have a clinical indication for revascularization
- •Are a candidate for either HCR or CABG or both
- •Anatomy suitable for HCR shall include
- •Multi-vessel CAD involving the LAD and/or
- •LAD disease and involvement of a major diagonal artery, both of which require revascularization
排除标准
- •Prior cardiac operations
- •Severe left ventricular dysfunction with ejection fraction (EF) < 30%
- •Patients with chest radiation
- •Body mass index (BMI) > 35
- •Severe peripheral vascular disease (PVD)
- •Acute ischemia requiring emergent traditional coronary artery bypass graft (CABG)
结局指标
主要结局
Comparison of major adverse cardiac and cerebrovascular events (MACCE) between groups
时间窗: Up to one year
Major adverse cardiac and cerebrovascular events (MACCE) will be assessed at 30 days and at one year after the index procedure. For the purpose of this trial, the components of MACCE include (1) all-cause mortality, (2) repeat revascularization, (3) stroke, and (4) myocardial infarction.
次要结局
- Comparison of repeat revascularization between groups(Up to one year)
- Comparison of atrial fibrillation between groups(During hospitalization (typically 3-8 days))
- Comparison of ventilator time between groups(During hospitalization (typically 3-8 days))
- Comparison of chest tube drainage complications between groups(During hospitalization (typically 3-8 days))
- Comparison of hospital length of stay between groups(During hospitalization (typically 3-8 days))
- Comparison of Angina Score between groups(Up to one year)
- Comparison of Duke Activity Scale Index (DASI) scores between groups(Up to one year)
- Comparison of all-cause mortality between groups(Up to one year)
- Comparison of ischemia-driven repeat revascularization between groups(Up to one year)
- Comparison of wound infection between groups(During hospitalization (typically 3-8 days))
- Comparison of hospital readmission between groups(Up to one year)
- Comparison of stroke between groups(Up to one year)
- Comparison of surgical re-exploration between groups(During hospitalization (typically 3-8 days))
- Comparison of blood transfusion between groups(During hospitalization (typically 3-8 days))
- Comparison of EuroQol EQ-5D scores between groups(Up to one year)
研究者
Michael Halkos
Associate Professor of Surgery
Emory University