Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

Phase 3

Completed

• Conditions: Carotid Stenosis; Coronary Stenosis
• Interventions: Other: Preoperative coronary angiography; Other: Standard cardiac workup

• 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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-07
• Study Completion: 2012-06
• Status Verified: 2014-10
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Study First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

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

Arm && Interventions

Group	Intervention	Description
A - Coronary angiography	Preoperative coronary angiography	All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)
B - standard cardiac workup	Standard cardiac workup	Standard cardiac workup

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