Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 主要终点
- Non-fatal and fatal myocardial infarction
研究概览
简要总结
The purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy (CEA).
详细描述
Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n = 210) CEA was performed without coronary angiography.
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
- None
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 carotid endarterectomy
- •no clinical sign or history of ischemic heart disease
- •no electrical signs of cardiac ischemia
- •left ventricular ejection fraction >50% at transthoracic echocardiogram.
排除标准
- •disabling stroke (mRS ≥3)
- •non atherosclerotic carotid disease
- •severe intracranial carotid artery stenosis
- •contra-indications to heparin, aspirin or clopidogrel.
结局指标
主要结局
Non-fatal and fatal myocardial infarction
时间窗: 30 days through year 3
次要结局
- All-cause and cardiovascular mortality(30 days through year 3)
研究者
Giulio Illuminati
Associate Professor of Surgery
University of Roma La Sapienza