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

October 8, 2014 updated by: Giulio Illuminati, University of Roma La Sapienza

Randomized Controlled Trial Analyzing the Role of Systematic Preoperative 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

426

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A - Coronary angiography
All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)
Other: Preoperative coronary angiography
If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
Active Comparator: B - standard cardiac workup
Standard cardiac workup
Other: Standard cardiac workup
EKG, transthoracic cardiac echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-fatal and fatal myocardial infarction
Time Frame: 30 days through year 3
30 days through year 3

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause and cardiovascular mortality
Time Frame: 30 days through year 3
30 days through year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Giulio Illuminati, MD, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University "La Sapienza" Rome

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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