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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2012-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Carotid Stenosis Coronary Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - Coronary angiography

All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)

Group Type ACTIVE_COMPARATOR

Preoperative coronary angiography

Intervention Type OTHER

If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied

B - standard cardiac workup

Standard cardiac workup

Group Type ACTIVE_COMPARATOR

Standard cardiac workup

Intervention Type OTHER

EKG, transthoracic cardiac echocardiogram

Interventions

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Preoperative coronary angiography

If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied

Intervention Type OTHER

Standard cardiac workup

EKG, transthoracic cardiac echocardiogram

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No