<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/NCT01668290</url>
  </required_header>
  <id_info>
    <org_study_id>CMI 1D</org_study_id>
    <secondary_id>Pro00026591</secondary_id>
    <nct_id>NCT01668290</nct_id>
  </id_info>
  <brief_title>Assessment of Patients With Suspected Coronary Artery Disease (CAD): What is the Best Initial Imaging Strategy?</brief_title>
  <acronym>IMAGE-CAD</acronym>
  <official_title>Assessment of Patients With Suspected CAD: What is the Best Initial Imaging Strategy? Cardiac Computed Tomographic Angiography,(CCTA) vs Stress Echocardiography (SE) vs SPECT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harald Becher</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Health services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who present with chest pain are investigated with tests designed to confirm or&#xD;
      exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor&#xD;
      outcome. It is not known which imaging test would be best when used first for investigating a&#xD;
      patient presenting with exertional chest pain. This trial is designed to compare outcomes of&#xD;
      the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot&#xD;
      study. Patients with no history of coronary disease presenting with chest pain will be&#xD;
      randomly assigned to one of the three test modalities as the initial imaging test. The three&#xD;
      imaging strategies will be compared regarding the subsequent use of healthcare resources over&#xD;
      a year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study on imaging strategies for diagnosis of coronary artery disease. The&#xD;
      pilot trial aims to answer the question &quot;Which non-invasive test (single photon emission&#xD;
      computed tomography (SPECT), stress echocardiography or coronary CT angiography (CCTA)) is&#xD;
      the best first test in suspected coronary artery disease with respect to patient outcome and&#xD;
      downstream health costs?&quot; Patients are randomly assigned to one of the imaging modalities.&#xD;
      All imaging and therapeutic procedures in this trial are clinically indicated. The only&#xD;
      change from standard patient management is the selection of the initial imaging test. Instead&#xD;
      of leaving the selection of the initial imaging test to the referring physician (whose&#xD;
      decision is not evidence based), patients presenting with chest pain that fall into the&#xD;
      inclusion/exclusion criteria of the study will be randomly assigned to one of the imaging&#xD;
      modalities. Patients will also be followed at 1, 6 and 12 months after enrolment to determine&#xD;
      outcomes. The three imaging strategies will be compared regarding subsequent use of&#xD;
      healthcare resources over a year. In most large cardiac centres, different imaging modalities&#xD;
      are performed by different specialists and therefore an operating grant from one imaging&#xD;
      specialty rarely covers the costs of other imaging specialties in comparative studies. To&#xD;
      ensure a fair comparison between modalities, all modalities have to be equal. Previous&#xD;
      comparative trials have been criticized for being biased towards the technique being promoted&#xD;
      by the principal investigator. This trial is unique in that the directors of nuclear&#xD;
      cardiology, coronary computed tomography and echocardiography are all specialists in their&#xD;
      field and are running state-of-the-art services and were all involved in the early planning&#xD;
      of this trial and their involvement has ensured trial design meets clinical need. The results&#xD;
      of this trial will give insight into planning of a larger multicentre, multi-national study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>healthcare resource utilization</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>referral rates to coronary angiography following three different initial imaging tests in this patient population.</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coronary lesions which warrant revascularization (including those where it was warranted but not technically possible).</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiation exposure from the initial and subsequent imaging procedures</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total mortality</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>freedom from angina</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>non-fatal myocardial infarction</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital admissions for angina</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">173</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Stress Echocardiography</arm_group_label>
    <description>Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Stress Echocardiography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPECT</arm_group_label>
    <description>Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Single Photon Emission Computed Tomography (SPECT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CCTA</arm_group_label>
    <description>Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Cardiac Computed Tomographic Angiography (CCTA)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women without known CAD who present with symptoms suggestive of CAD and require&#xD;
        diagnostic/prognostic workup.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Age ≥ 18 years&#xD;
&#xD;
          -  Presenting with symptoms suggestive of CAD requiring diagnostic/prognostic workup&#xD;
&#xD;
          -  Suitable for Contrast Stress Echocardiography, SPECT and CCTA&#xD;
&#xD;
          -  Able and willing to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with documented CAD (previous invasive angiography, previous STEMI, previous&#xD;
             PCI or CABG)&#xD;
&#xD;
          -  NSTEMI, ACS within 3 months&#xD;
&#xD;
          -  Previous diagnostic imaging tests in the past 6 months&#xD;
&#xD;
          -  Women who are pregnant as evidenced by positive pregnancy test&#xD;
&#xD;
          -  Breast feeding females&#xD;
&#xD;
          -  Significant valvular heart disease (i.e. severe aortic stenosis or regurgitation or&#xD;
             severe mitral regurgitation)&#xD;
&#xD;
          -  Hemodynamic instability (blood pressure &gt;210/110 ml/Hg or &lt;90/60 mm/Hg)&#xD;
&#xD;
          -  Unavailability for follow-up&#xD;
&#xD;
          -  Renal insufficiency, eGFR &lt; 30 ml/minute unless on dialysis&#xD;
&#xD;
          -  Known allergy to x-ray or echo contrast agents&#xD;
&#xD;
          -  Weight exceeding specifications of nuclear equipment (&gt;250 Kg)&#xD;
&#xD;
          -  Unable to give informed consent&#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>Harald Becher, MD,PhD,FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta, Alberta Health Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mazankowski Alberta Heart Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>March 15, 2017</last_update_submitted>
  <last_update_submitted_qc>March 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Harald Becher</investigator_full_name>
    <investigator_title>Heart and Stroke Foundation Chair for Cardiovascular Research</investigator_title>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Stress Echocardiography</keyword>
  <keyword>Single Photon Emission Computed Tomography</keyword>
  <keyword>Cardiac Computed Tomographic Angiography</keyword>
  <keyword>outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01668290
org study id: CMI 1D
secondary id: Pro00026591
nct id: NCT01668290
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Patients who present with chest pain are investigated with tests designed to confirm or
      exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor
      outcome. It is not known which imaging test would be best when used first for investigating a
      patient presenting with exertional chest pain. This trial is designed to compare outcomes of
      the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot
      study. Patients with no history of coronary disease presenting with chest pain will be
      randomly assigned to one of the three test modalities as the initial imaging test. The three
      imaging strategies will be compared regarding the subsequent use of healthcare resources over
      a year.
This is a pilot study on imaging strategies for diagnosis of coronary artery disease. The
      pilot trial aims to answer the question "Which non-invasive test (single photon emission
      computed tomography (SPECT), stress echocardiography or coronary CT angiography (CCTA)) is
      the best first test in suspected coronary artery disease with respect to patient outcome and
      downstream health costs?" Patients are randomly assigned to one of the imaging modalities.
      All imaging and therapeutic procedures in this trial are clinically indicated. The only
      change from standard patient management is the selection of the initial imaging test. Instead
      of leaving the selection of the initial imaging test to the referring physician (whose
      decision is not evidence based), patients presenting with chest pain that fall into the
      inclusion/exclusion criteria of the study will be randomly assigned to one of the imaging
      modalities. Patients will also be followed at 1, 6 and 12 months after enrolment to determine
      outcomes. The three imaging strategies will be compared regarding subsequent use of
      healthcare resources over a year. In most large cardiac centres, different imaging modalities
      are performed by different specialists and therefore an operating grant from one imaging
      specialty rarely covers the costs of other imaging specialties in comparative studies. To
      ensure a fair comparison between modalities, all modalities have to be equal. Previous
      comparative trials have been criticized for being biased towards the technique being promoted
      by the principal investigator. This trial is unique in that the directors of nuclear
      cardiology, coronary computed tomography and echocardiography are all specialists in their
      field and are running state-of-the-art services and were all involved in the early planning
      of this trial and their involvement has ensured trial design meets clinical need. The results
      of this trial will give insight into planning of a larger multicentre, multi-national study.
observational model: Cohort
time perspective: Prospective
measure: healthcare resource utilization
time frame: 12 month
measure: referral rates to coronary angiography following three different initial imaging tests in this patient population.
time frame: 12 month
measure: coronary lesions which warrant revascularization (including those where it was warranted but not technically possible).
time frame: 12 month
measure: radiation exposure from the initial and subsequent imaging procedures
time frame: 12 month
measure: total mortality
time frame: 12 month
measure: freedom from angina
time frame: 12 month
measure: non-fatal myocardial infarction
time frame: 12 month
measure: hospital admissions for angina
time frame: 12 month
arm group label: Stress Echocardiography
description: Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Stress Echocardiography.
arm group label: SPECT
description: Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Single Photon Emission Computed Tomography (SPECT)
arm group label: CCTA
description: Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Cardiac Computed Tomographic Angiography (CCTA)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harald Becher, MD,PhD,FRCP
role: Principal Investigator
affiliation: University of Alberta, Alberta Health Services
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: University of Alberta
investigator full name: Harald Becher
investigator title: Heart and Stroke Foundation Chair for Cardiovascular Research
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No