<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01664858</url>
  </required_header>
  <id_info>
    <org_study_id>SP/12/1/29062</org_study_id>
    <nct_id>NCT01664858</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease-2</brief_title>
  <acronym>CE-MARC2</acronym>
  <official_title>Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease - 2 (CE-MARC2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in&#xD;
      patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic&#xD;
      Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical&#xD;
      practice (defined by international guidelines). The study hypothesis is that 3Tesla&#xD;
      CMR-guided management of patients with suspected stable angina is superior to current&#xD;
      clinical practice based on 1) the principles of the National Institutes for Clinical&#xD;
      Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of&#xD;
      avoiding study-defined unnecessary invasive coronary angiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized controlled trial of non-invasive imaging to determine diagnosis and&#xD;
      management of patients presenting with suspected stable angina. Despite the widespread&#xD;
      availability of non-invasive imaging and guideline-enshrined use of optimal medical therapy&#xD;
      (OMT), patients with suspected coronary heart disease (CHD) often end up having invasive&#xD;
      coronary angiography early in their disease course. Currently &gt;50% of elective invasive&#xD;
      coronary angiograms performed in the UK and US do not lead on to a revascularisation&#xD;
      procedure (data from 2008-09 UK Hospital Episode Statistics; American College of Cardiology&#xD;
      National Cardiovascular Data Registry (Patel MR, et al., N Engl J Med 2010;362:886-95)). The&#xD;
      UK NICE guidelines for the management of chest pain of recent onset (CG95; 2010) could&#xD;
      increase this proportion even further. This is inefficient for patients and also of&#xD;
      healthcare resources.&#xD;
&#xD;
      More widespread use of non-invasive functional imaging could reduce the rates of unnecessary&#xD;
      angiography. We have shown in the CE-MARC study (Lancet 2012) that cardiovascular magnetic&#xD;
      resonance (CMR) at 1.5Tesla has a higher diagnostic accuracy for the detection of CHD than&#xD;
      single-photon emission computed tomography (SPECT). CE-MARC 2 will be a three-way randomised&#xD;
      controlled trial of patient management in 1200 patients with known or suspected CHD,&#xD;
      comparing 3Tesla CMR to SPECT-guided care or NICE guidelines-based management. The primary&#xD;
      endpoint will be the reduction of unnecessary invasive angiography (defined by invasive FFR)&#xD;
      at 12 months - identified by our expert patients as an important 'patient focused' clinical&#xD;
      outcome measure. The secondary objectives will include: 1) assessment of safety of a&#xD;
      CMR-guided management strategy 2) cost effectiveness analysis of these strategies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Unnecessary Invasive Coronary Angiography</measure>
    <time_frame>12 months</time_frame>
    <description>A negative FFR and positive non-invasive test (either 3T CMR or SPECT/CCT)&#xD;
A negative FFR in a high pre-test risk (61-90%) patient that proceeds directly to invasive angiography in the NICE guidelines-based strategy arm&#xD;
A negative FFR and a negative non-invasive test (either 3T CMR or SPECT/CCT) (i.e. a True Negative strategy result in which the imaging result was 'not believed' by the treating cardiologist)&#xD;
An inconclusive non-invasive test result (either 3T CMR or SPECT/CCT) in which angiography had to be performed to make the diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiovascular Event (MACE)</measure>
    <time_frame>at 12 months</time_frame>
    <description>MACE is defined as one of the following:&#xD;
Death due to cardiovascular cause (including type 3 MI) †&#xD;
Myocardial infarction†&#xD;
Unplanned revascularisation&#xD;
Hospital admission for cardiovascular cause [ACS Troponin -ve, spontaneous myocardial infarction (Type 1)†, Myocardial infarction secondary to ischaemic imbalance (Type 2) †, Myocardial Infarction related to stent thrombosis (Type 4b) †, Arrhythmia, Stroke, Heart failure]. † As defined by the third universal definition of myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Angiogram (by FFR) Rate for Each Strategy.</measure>
    <time_frame>12 months</time_frame>
    <description>The Positive Angiogram rate will be determined from the proportion of patients in the relevant population who undergo an angiogram within 12 months of randomisation which yields a positive finding by FFR (or QCA where no FFR reading is undertaken)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Effectiveness Analysis</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the long term cost-effectiveness of the alternate diagnostic testing strategies, information from the trial will be used to update the economic model developed as part of the original CE-MARC trial. The model will use information from the trial, including on resource use, costs, HRQoL and other clinical outcomes (e.g. on unnecessary tests and MACE events), together with epidemiological, clinical and economic data from other sources to calculate costs and quality-adjusted life-years (QALYs) for patients. The economic analysis will use methods consistent with those recommended by the National Institute for Health and Clinical Excellence (NICE). Given the potential difference between diagnostic strategies in terms of mortality, the modelling will adopt a lifetime time horizon to capture any difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D)</measure>
    <time_frame>3 years</time_frame>
    <description>Health-related quality-of-life (HRQoL) will be measured at baseline (in clinic), 6 months, 12 months, 2yrs and 3yrs (by post), using the following validated questionnaires:&#xD;
Seattle Angina Questionnaire (SAQ) - UK version&#xD;
SF12v2&#xD;
EuroQol (EQ-5D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>3 years</time_frame>
    <description>Complications - investigational or procedural related only. All complications from all study procedures/investigations will be recorded and reported if they result in an extended length of stay or specific treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1202</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>3T CMR-guided management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient to be managed according to the results of 3T CMR imaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPECT-guided management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients to be managed according to the results of SPECT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NICE-guidelines based management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3T CMR</intervention_name>
    <description>3Tesla Cardiac Magnetic Resonance Imaging</description>
    <arm_group_label>3T CMR-guided management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SPECT</intervention_name>
    <description>SPECT: Single Photon Emission Computed Tomography</description>
    <arm_group_label>NICE-guidelines based management</arm_group_label>
    <arm_group_label>SPECT-guided management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT calcium score</intervention_name>
    <description>CT calcium score</description>
    <arm_group_label>NICE-guidelines based management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT coronary angiography</intervention_name>
    <description>CT coronary angiography</description>
    <arm_group_label>NICE-guidelines based management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>X-Ray coronary angiography</intervention_name>
    <description>X-Ray coronary angiography</description>
    <arm_group_label>3T CMR-guided management</arm_group_label>
    <arm_group_label>NICE-guidelines based management</arm_group_label>
    <arm_group_label>SPECT-guided management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥30yrs&#xD;
&#xD;
          -  Patient has suspected stable angina (CHD) that requires further investigation&#xD;
&#xD;
          -  Has a defined risk of 10-90% (according to NICE guidelines CG95; 2010)&#xD;
&#xD;
          -  Suitable for revascularisation if required&#xD;
&#xD;
          -  Given informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-anginal chest pain&#xD;
&#xD;
          -  Clinically unstable&#xD;
&#xD;
          -  Previous MI or biomarker positive ACS&#xD;
&#xD;
          -  Previous revascularisation with coronary artery bypass surgery or PCI&#xD;
&#xD;
          -  Contraindication to CMR imaging (pacemaker, intra-orbital debris, intra-auricular&#xD;
             implants, intracranial clips, severe claustrophobia)&#xD;
&#xD;
          -  Contraindication to adenosine infusion (regular adenosine antagonist medication,&#xD;
             significant reversible airways disease, second or third degree atrio-ventricular heart&#xD;
             block, sino-atrial disease)&#xD;
&#xD;
          -  Known adverse reaction to Adenosine or Gadolinium contrast agent&#xD;
&#xD;
          -  Obesity (where body girth exceeds scanner diameter)&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Known chronic renal failure (eGFR &lt;30mL/min/1.73m2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John P Greenwood, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS FT</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Georges Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Ripley DP, Brown JM, Everett CC, Bijsterveld P, Walker S, Sculpher M, McCann GP, Berry C, Plein S, Greenwood JP. Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): a prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease. Am Heart J. 2015 Jan;169(1):17-24.e1. doi: 10.1016/j.ahj.2014.10.008. Epub 2014 Oct 22.</citation>
    <PMID>25497243</PMID>
  </reference>
  <results_reference>
    <citation>Greenwood JP, Ripley DP, Berry C, McCann GP, Plein S, Bucciarelli-Ducci C, Dall'Armellina E, Prasad A, Bijsterveld P, Foley JR, Mangion K, Sculpher M, Walker S, Everett CC, Cairns DA, Sharples LD, Brown JM; CE-MARC 2 Investigators. Effect of Care Guided by Cardiovascular Magnetic Resonance, Myocardial Perfusion Scintigraphy, or NICE Guidelines on Subsequent Unnecessary Angiography Rates: The CE-MARC 2 Randomized Clinical Trial. JAMA. 2016 Sep 13;316(10):1051-60. doi: 10.1001/jama.2016.12680.</citation>
    <PMID>27570866</PMID>
  </results_reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>October 27, 2016</results_first_submitted>
  <results_first_submitted_qc>May 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 23, 2018</results_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Professor JP Greenwood</investigator_full_name>
    <investigator_title>Professor of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Coronary Heart Disease</keyword>
  <keyword>Ischaemic Heart Disease</keyword>
  <keyword>Angina</keyword>
  <keyword>Cardiac Magnetic Resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>3T CMR-guided Management</title>
          <description>Patient to be managed according to the results of 3T CMR imaging&#xD;
3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
        </group>
        <group group_id="P2">
          <title>SPECT-guided Management</title>
          <description>Patients to be managed according to the results of SPECT&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
        </group>
        <group group_id="P3">
          <title>NICE-guidelines Based Management</title>
          <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
CT calcium score: CT calcium score&#xD;
CT coronary angiography: CT coronary angiography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="481"/>
                <participants group_id="P2" count="481"/>
                <participants group_id="P3" count="240"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="467"/>
                <participants group_id="P2" count="468"/>
                <participants group_id="P3" count="234"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>3T CMR-guided Management</title>
          <description>Patient to be managed according to the results of 3T CMR imaging&#xD;
3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging&#xD;
X-Ray coronary angiography: X-Ray coronary angiography&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .</description>
        </group>
        <group group_id="B2">
          <title>SPECT-guided Management</title>
          <description>Patients to be managed according to the results of SPECT&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .</description>
        </group>
        <group group_id="B3">
          <title>NICE-guidelines Based Management</title>
          <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
CT calcium score: CT calcium score&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .&#xD;
CT coronary angiography: CT coronary angiography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="481"/>
            <count group_id="B2" value="481"/>
            <count group_id="B3" value="240"/>
            <count group_id="B4" value="1202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.5" spread="9.10"/>
                    <measurement group_id="B2" value="55.9" spread="8.87"/>
                    <measurement group_id="B3" value="56.5" spread="9.21"/>
                    <measurement group_id="B4" value="56.3" spread="9.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="227"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="112"/>
                    <measurement group_id="B4" value="564"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="254"/>
                    <measurement group_id="B2" value="256"/>
                    <measurement group_id="B3" value="128"/>
                    <measurement group_id="B4" value="638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unnecessary Invasive Coronary Angiography</title>
        <description>A negative FFR and positive non-invasive test (either 3T CMR or SPECT/CCT)&#xD;
A negative FFR in a high pre-test risk (61-90%) patient that proceeds directly to invasive angiography in the NICE guidelines-based strategy arm&#xD;
A negative FFR and a negative non-invasive test (either 3T CMR or SPECT/CCT) (i.e. a True Negative strategy result in which the imaging result was 'not believed' by the treating cardiologist)&#xD;
An inconclusive non-invasive test result (either 3T CMR or SPECT/CCT) in which angiography had to be performed to make the diagnosis</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3T CMR-guided Management</title>
            <description>Patient to be managed according to the results of 3T CMR imaging&#xD;
3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging&#xD;
X-Ray coronary angiography: X-Ray coronary angiography&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .</description>
          </group>
          <group group_id="O2">
            <title>SPECT-guided Management</title>
            <description>Patients to be managed according to the results of SPECT&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .</description>
          </group>
          <group group_id="O3">
            <title>NICE-guidelines Based Management</title>
            <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
CT calcium score: CT calcium score&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .&#xD;
CT coronary angiography: CT coronary angiography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unnecessary Invasive Coronary Angiography</title>
          <description>A negative FFR and positive non-invasive test (either 3T CMR or SPECT/CCT)&#xD;
A negative FFR in a high pre-test risk (61-90%) patient that proceeds directly to invasive angiography in the NICE guidelines-based strategy arm&#xD;
A negative FFR and a negative non-invasive test (either 3T CMR or SPECT/CCT) (i.e. a True Negative strategy result in which the imaging result was 'not believed' by the treating cardiologist)&#xD;
An inconclusive non-invasive test result (either 3T CMR or SPECT/CCT) in which angiography had to be performed to make the diagnosis</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="481"/>
                <count group_id="O2" value="481"/>
                <count group_id="O3" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Adverse Cardiovascular Event (MACE)</title>
        <description>MACE is defined as one of the following:&#xD;
Death due to cardiovascular cause (including type 3 MI) †&#xD;
Myocardial infarction†&#xD;
Unplanned revascularisation&#xD;
Hospital admission for cardiovascular cause [ACS Troponin -ve, spontaneous myocardial infarction (Type 1)†, Myocardial infarction secondary to ischaemic imbalance (Type 2) †, Myocardial Infarction related to stent thrombosis (Type 4b) †, Arrhythmia, Stroke, Heart failure]. † As defined by the third universal definition of myocardial infarction.</description>
        <time_frame>at 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3T CMR-guided Management</title>
            <description>Patient to be managed according to the results of 3T CMR imaging&#xD;
3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>SPECT-guided Management</title>
            <description>Patients to be managed according to the results of SPECT&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
          <group group_id="O3">
            <title>NICE-guidelines Based Management</title>
            <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
CT calcium score: CT calcium score&#xD;
CT coronary angiography: CT coronary angiography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Major Adverse Cardiovascular Event (MACE)</title>
          <description>MACE is defined as one of the following:&#xD;
Death due to cardiovascular cause (including type 3 MI) †&#xD;
Myocardial infarction†&#xD;
Unplanned revascularisation&#xD;
Hospital admission for cardiovascular cause [ACS Troponin -ve, spontaneous myocardial infarction (Type 1)†, Myocardial infarction secondary to ischaemic imbalance (Type 2) †, Myocardial Infarction related to stent thrombosis (Type 4b) †, Arrhythmia, Stroke, Heart failure]. † As defined by the third universal definition of myocardial infarction.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="481"/>
                <count group_id="O2" value="481"/>
                <count group_id="O3" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Angiogram (by FFR) Rate for Each Strategy.</title>
        <description>The Positive Angiogram rate will be determined from the proportion of patients in the relevant population who undergo an angiogram within 12 months of randomisation which yields a positive finding by FFR (or QCA where no FFR reading is undertaken)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3T CMR-guided Management</title>
            <description>Patient to be managed according to the results of 3T CMR imaging&#xD;
3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
          <group group_id="O2">
            <title>SPECT-guided Management</title>
            <description>Patients to be managed according to the results of SPECT&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
          <group group_id="O3">
            <title>NICE-guidelines Based Management</title>
            <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
CT calcium score: CT calcium score&#xD;
CT coronary angiography: CT coronary angiography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Angiogram (by FFR) Rate for Each Strategy.</title>
          <description>The Positive Angiogram rate will be determined from the proportion of patients in the relevant population who undergo an angiogram within 12 months of randomisation which yields a positive finding by FFR (or QCA where no FFR reading is undertaken)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="481"/>
                <count group_id="O2" value="481"/>
                <count group_id="O3" value="240"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost Effectiveness Analysis</title>
        <description>To assess the long term cost-effectiveness of the alternate diagnostic testing strategies, information from the trial will be used to update the economic model developed as part of the original CE-MARC trial. The model will use information from the trial, including on resource use, costs, HRQoL and other clinical outcomes (e.g. on unnecessary tests and MACE events), together with epidemiological, clinical and economic data from other sources to calculate costs and quality-adjusted life-years (QALYs) for patients. The economic analysis will use methods consistent with those recommended by the National Institute for Health and Clinical Excellence (NICE). Given the potential difference between diagnostic strategies in terms of mortality, the modelling will adopt a lifetime time horizon to capture any difference.</description>
        <time_frame>3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D)</title>
        <description>Health-related quality-of-life (HRQoL) will be measured at baseline (in clinic), 6 months, 12 months, 2yrs and 3yrs (by post), using the following validated questionnaires:&#xD;
Seattle Angina Questionnaire (SAQ) - UK version&#xD;
SF12v2&#xD;
EuroQol (EQ-5D)</description>
        <time_frame>3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications</title>
        <description>Complications - investigational or procedural related only. All complications from all study procedures/investigations will be recorded and reported if they result in an extended length of stay or specific treatment.</description>
        <time_frame>3 years</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.</desc>
      <group_list>
        <group group_id="E1">
          <title>3T CMR-guided Management</title>
          <description>Patient to be managed according to the results of 3T CMR imaging&#xD;
3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging&#xD;
X-Ray coronary angiography: X-Ray coronary angiography&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .</description>
        </group>
        <group group_id="E2">
          <title>SPECT-guided Management</title>
          <description>Patients to be managed according to the results of SPECT&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .</description>
        </group>
        <group group_id="E3">
          <title>NICE-guidelines Based Management</title>
          <description>Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.&#xD;
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography&#xD;
SPECT: SPECT: Single Photon Emission Computed Tomography&#xD;
CT calcium score: CT calcium score&#xD;
Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test .&#xD;
CT coronary angiography: CT coronary angiography&#xD;
X-Ray coronary angiography: X-Ray coronary angiography</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="481"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="481"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Major Adverse Cardiovascular Event</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="481"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="481"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="481"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Expected Test Complication</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="481"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="481"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="240"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor John P Greenwood</name_or_title>
      <organization>University of Leeds</organization>
      <phone>+44 (0)113 3925481</phone>
      <email>j.greenwood@leeds.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01664858
org study id: SP/12/1/29062
nct id: NCT01664858
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in
      patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic
      Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical
      practice (defined by international guidelines). The study hypothesis is that 3Tesla
      CMR-guided management of patients with suspected stable angina is superior to current
      clinical practice based on 1) the principles of the National Institutes for Clinical
      Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of
      avoiding study-defined unnecessary invasive coronary angiography.
The study is a randomized controlled trial of non-invasive imaging to determine diagnosis and
      management of patients presenting with suspected stable angina. Despite the widespread
      availability of non-invasive imaging and guideline-enshrined use of optimal medical therapy
      (OMT), patients with suspected coronary heart disease (CHD) often end up having invasive
      coronary angiography early in their disease course. Currently >50% of elective invasive
      coronary angiograms performed in the UK and US do not lead on to a revascularisation
      procedure (data from 2008-09 UK Hospital Episode Statistics; American College of Cardiology
      National Cardiovascular Data Registry (Patel MR, et al., N Engl J Med 2010;362:886-95)). The
      UK NICE guidelines for the management of chest pain of recent onset (CG95; 2010) could
      increase this proportion even further. This is inefficient for patients and also of
      healthcare resources.

      More widespread use of non-invasive functional imaging could reduce the rates of unnecessary
      angiography. We have shown in the CE-MARC study (Lancet 2012) that cardiovascular magnetic
      resonance (CMR) at 1.5Tesla has a higher diagnostic accuracy for the detection of CHD than
      single-photon emission computed tomography (SPECT). CE-MARC 2 will be a three-way randomised
      controlled trial of patient management in 1200 patients with known or suspected CHD,
      comparing 3Tesla CMR to SPECT-guided care or NICE guidelines-based management. The primary
      endpoint will be the reduction of unnecessary invasive angiography (defined by invasive FFR)
      at 12 months - identified by our expert patients as an important 'patient focused' clinical
      outcome measure. The secondary objectives will include: 1) assessment of safety of a
      CMR-guided management strategy 2) cost effectiveness analysis of these strategies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants With Unnecessary Invasive Coronary Angiography
time frame: 12 months
description: A negative FFR and positive non-invasive test (either 3T CMR or SPECT/CCT)
A negative FFR in a high pre-test risk (61-90%) patient that proceeds directly to invasive angiography in the NICE guidelines-based strategy arm
A negative FFR and a negative non-invasive test (either 3T CMR or SPECT/CCT) (i.e. a True Negative strategy result in which the imaging result was 'not believed' by the treating cardiologist)
An inconclusive non-invasive test result (either 3T CMR or SPECT/CCT) in which angiography had to be performed to make the diagnosis
measure: Major Adverse Cardiovascular Event (MACE)
time frame: at 12 months
description: MACE is defined as one of the following:
Death due to cardiovascular cause (including type 3 MI) †
Myocardial infarction†
Unplanned revascularisation
Hospital admission for cardiovascular cause [ACS Troponin -ve, spontaneous myocardial infarction (Type 1)†, Myocardial infarction secondary to ischaemic imbalance (Type 2) †, Myocardial Infarction related to stent thrombosis (Type 4b) †, Arrhythmia, Stroke, Heart failure]. † As defined by the third universal definition of myocardial infarction.
measure: Positive Angiogram (by FFR) Rate for Each Strategy.
time frame: 12 months
description: The Positive Angiogram rate will be determined from the proportion of patients in the relevant population who undergo an angiogram within 12 months of randomisation which yields a positive finding by FFR (or QCA where no FFR reading is undertaken)
measure: Cost Effectiveness Analysis
time frame: 3 years
description: To assess the long term cost-effectiveness of the alternate diagnostic testing strategies, information from the trial will be used to update the economic model developed as part of the original CE-MARC trial. The model will use information from the trial, including on resource use, costs, HRQoL and other clinical outcomes (e.g. on unnecessary tests and MACE events), together with epidemiological, clinical and economic data from other sources to calculate costs and quality-adjusted life-years (QALYs) for patients. The economic analysis will use methods consistent with those recommended by the National Institute for Health and Clinical Excellence (NICE). Given the potential difference between diagnostic strategies in terms of mortality, the modelling will adopt a lifetime time horizon to capture any difference.
measure: Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D)
time frame: 3 years
description: Health-related quality-of-life (HRQoL) will be measured at baseline (in clinic), 6 months, 12 months, 2yrs and 3yrs (by post), using the following validated questionnaires:
Seattle Angina Questionnaire (SAQ) - UK version
SF12v2
EuroQol (EQ-5D)
measure: Complications
time frame: 3 years
description: Complications - investigational or procedural related only. All complications from all study procedures/investigations will be recorded and reported if they result in an extended length of stay or specific treatment.
arm group label: 3T CMR-guided management
arm group type: Active Comparator
description: Patient to be managed according to the results of 3T CMR imaging
arm group label: SPECT-guided management
arm group type: Active Comparator
description: Patients to be managed according to the results of SPECT
arm group label: NICE-guidelines based management
arm group type: Active Comparator
description: Patients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD.
10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography
intervention type: Other
intervention name: 3T CMR
description: 3Tesla Cardiac Magnetic Resonance Imaging
arm group label: 3T CMR-guided management
intervention type: Other
intervention name: SPECT
description: SPECT: Single Photon Emission Computed Tomography
arm group label: NICE-guidelines based management
arm group label: SPECT-guided management
intervention type: Other
intervention name: CT calcium score
description: CT calcium score
arm group label: NICE-guidelines based management
intervention type: Other
intervention name: CT coronary angiography
description: CT coronary angiography
arm group label: NICE-guidelines based management
intervention type: Other
intervention name: X-Ray coronary angiography
description: X-Ray coronary angiography
arm group label: 3T CMR-guided management
arm group label: NICE-guidelines based management
arm group label: SPECT-guided management
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: John P Greenwood, PhD
role: Principal Investigator
affiliation: University of Leeds
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Ripley DP, Brown JM, Everett CC, Bijsterveld P, Walker S, Sculpher M, McCann GP, Berry C, Plein S, Greenwood JP. Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): a prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease. Am Heart J. 2015 Jan;169(1):17-24.e1. doi: 10.1016/j.ahj.2014.10.008. Epub 2014 Oct 22.
PMID: 25497243
citation: Greenwood JP, Ripley DP, Berry C, McCann GP, Plein S, Bucciarelli-Ducci C, Dall'Armellina E, Prasad A, Bijsterveld P, Foley JR, Mangion K, Sculpher M, Walker S, Everett CC, Cairns DA, Sharples LD, Brown JM; CE-MARC 2 Investigators. Effect of Care Guided by Cardiovascular Magnetic Resonance, Myocardial Perfusion Scintigraphy, or NICE Guidelines on Subsequent Unnecessary Angiography Rates: The CE-MARC 2 Randomized Clinical Trial. JAMA. 2016 Sep 13;316(10):1051-60. doi: 10.1001/jama.2016.12680.
PMID: 27570866
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Professor JP Greenwood
investigator title: Professor of Cardiology
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Calcium
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 