Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
Phase 3
Completed
- Conditions
- Carotid StenosisCoronary Stenosis
- Registration Number
- NCT02260453
- Lead Sponsor
- University of Roma La Sapienza
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
Inclusion Criteria
- 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.
Exclusion Criteria
- disabling stroke (mRS ≥3)
- non atherosclerotic carotid disease
- severe intracranial carotid artery stenosis
- contra-indications to heparin, aspirin or clopidogrel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Non-fatal and fatal myocardial infarction 30 days through year 3
- Secondary Outcome Measures
Name Time Method All-cause and cardiovascular mortality 30 days through year 3