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

University of Roma La Sapienza

Status and phase: Completed; Phase 3

Conditions: Carotid Stenosis; Coronary Stenosis

Treatments: Other: Standard cardiac workup; Other: Preoperative coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02260453

University "La Sapienza" Rome

Details and patient eligibility

About

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).

Full 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.

Enrollment: 426 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

A - Coronary angiography

Active Comparator group

Description:

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

Treatment:

Other: Preoperative coronary angiography

B - standard cardiac workup

Active Comparator group

Description:

Standard cardiac workup

Treatment:

Other: Standard cardiac workup