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

Primary Purpose

Carotid Stenosis, Coronary Stenosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Preoperative coronary angiography
Standard cardiac workup
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A - Coronary angiography

    B - standard cardiac workup

    Arm Description

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

    Standard cardiac workup

    Outcomes

    Primary Outcome Measures

    Non-fatal and fatal myocardial infarction

    Secondary Outcome Measures

    All-cause and cardiovascular mortality

    Full Information

    First Posted
    October 6, 2014
    Last Updated
    October 8, 2014
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02260453
    Brief Title
    Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
    Acronym
    CACEA
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carotid Stenosis, Coronary Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    426 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A - Coronary angiography
    Arm Type
    Active Comparator
    Arm Description
    All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)
    Arm Title
    B - standard cardiac workup
    Arm Type
    Active Comparator
    Arm Description
    Standard cardiac workup
    Intervention Type
    Other
    Intervention Name(s)
    Preoperative coronary angiography
    Intervention Description
    If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
    Intervention Type
    Other
    Intervention Name(s)
    Standard cardiac workup
    Intervention Description
    EKG, transthoracic cardiac echocardiogram
    Primary Outcome Measure Information:
    Title
    Non-fatal and fatal myocardial infarction
    Time Frame
    30 days through year 3
    Secondary Outcome Measure Information:
    Title
    All-cause and cardiovascular mortality
    Time Frame
    30 days through year 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giulio Illuminati, MD
    Organizational Affiliation
    University of Roma La Sapienza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25701070
    Citation
    Illuminati G, Schneider F, Greco C, Mangieri E, Schiariti M, Tanzilli G, Barilla F, Paravati V, Pizzardi G, Calio' F, Miraldi F, Macrina F, Totaro M, Greco E, Mazzesi G, Tritapepe L, Toscano M, Vietri F, Meyer N, Ricco JB. Long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease. Eur J Vasc Endovasc Surg. 2015 Apr;49(4):366-74. doi: 10.1016/j.ejvs.2014.12.030. Epub 2015 Feb 18.
    Results Reference
    derived

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

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