Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Carotid Stenosis
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 426
- Primary Endpoint
- Non-fatal and fatal myocardial infarction
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Giulio Illuminati
Associate Professor of Surgery
University of Roma La Sapienza
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Non-fatal and fatal myocardial infarction
Time Frame: 30 days through year 3
Secondary Outcomes
- All-cause and cardiovascular mortality(30 days through year 3)