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Completed

NCT Number: NCT02260453

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

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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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative coronary angiography

Other

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

Standard cardiac workup

Other

EKG, transthoracic cardiac echocardiogram

Primary outcomes

  1. Non-fatal and fatal myocardial infarction

    Time frame: 30 days through year 3

Secondary outcomes

  1. All-cause and cardiovascular mortality

    Time frame: 30 days through year 3

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

Acronym: CACEA

Important dates

Study start
2005
Primary completion
2009
Study completion
2012
First posted
Oct 9, 2014
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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