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

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ClinicalTrials.gov Identifier: NCT02260453
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Giulio Illuminati, 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).

Condition or disease Intervention/treatment Phase
Carotid Stenosis Coronary Stenosis Other: Preoperative coronary angiography Other: Standard cardiac workup Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
Study Start Date : January 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Non-fatal and fatal myocardial infarction [ Time Frame: 30 days through year 3 ]

Secondary Outcome Measures :
  1. All-cause and cardiovascular mortality [ Time Frame: 30 days through year 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260453


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Giulio Illuminati, MD University of Roma La Sapienza

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giulio Illuminati, Associate Professor of Surgery, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02260453     History of Changes
Other Study ID Numbers: University "La Sapienza" Rome
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Carotid Stenosis
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases