<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02260453</url>
  </required_header>
  <id_info>
    <org_study_id>University &quot;La Sapienza&quot; Rome</org_study_id>
    <nct_id>NCT02260453</nct_id>
  </id_info>
  <brief_title>Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease</brief_title>
  <acronym>CACEA</acronym>
  <official_title>Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the potential benefit of systematic preoperative&#xD;
      coronary angiography followed by selective coronary artery revascularization on the incidence&#xD;
      of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD)&#xD;
      and undergoing carotid endarterectomy (CEA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a&#xD;
      normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients&#xD;
      underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n&#xD;
      = 210) CEA was performed without coronary angiography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2005</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">July 2009</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-fatal and fatal myocardial infarction</measure>
    <time_frame>30 days through year 3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause and cardiovascular mortality</measure>
    <time_frame>30 days through year 3</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">426</enrollment>
  <condition>Carotid Stenosis</condition>
  <condition>Coronary Stenosis</condition>
  <arm_group>
    <arm_group_label>A - Coronary angiography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - standard cardiac workup</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard cardiac workup</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preoperative coronary angiography</intervention_name>
    <description>If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied</description>
    <arm_group_label>A - Coronary angiography</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard cardiac workup</intervention_name>
    <description>EKG, transthoracic cardiac echocardiogram</description>
    <arm_group_label>B - standard cardiac workup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for carotid endarterectomy&#xD;
&#xD;
          -  no clinical sign or history of ischemic heart disease&#xD;
&#xD;
          -  no electrical signs of cardiac ischemia&#xD;
&#xD;
          -  left ventricular ejection fraction &gt;50% at transthoracic echocardiogram.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disabling stroke (mRS ≥3)&#xD;
&#xD;
          -  non atherosclerotic carotid disease&#xD;
&#xD;
          -  severe intracranial carotid artery stenosis&#xD;
&#xD;
          -  contra-indications to heparin, aspirin or clopidogrel.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giulio Illuminati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Roma La Sapienza</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Giulio Illuminati</investigator_full_name>
    <investigator_title>Associate Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260453
org study id: University "La Sapienza" Rome
nct id: NCT02260453
lead sponsor: 
has dmc: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Non-fatal and fatal myocardial infarction
time frame: 30 days through year 3
measure: All-cause and cardiovascular mortality
time frame: 30 days through year 3
arm group label: A - Coronary angiography
arm group type: Active Comparator
description: All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG)
arm group label: B - standard cardiac workup
arm group type: Active Comparator
description: Standard cardiac workup
intervention type: Other
intervention name: Preoperative coronary angiography
description: If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
arm group label: A - Coronary angiography
intervention type: Other
intervention name: Standard cardiac workup
description: EKG, transthoracic cardiac echocardiogram
arm group label: B - standard cardiac workup
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giulio Illuminati, MD
role: Principal Investigator
affiliation: University of Roma La Sapienza
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Giulio Illuminati
investigator title: Associate Professor of Surgery
mesh term: Carotid Stenosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Coronary Stenosis
mesh term: Constriction, Pathologic