<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/NCT03231189</url>
  </required_header>
  <id_info>
    <org_study_id>AOM 16181</org_study_id>
    <nct_id>NCT03231189</nct_id>
  </id_info>
  <brief_title>Cardiac MRI in Front Line for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction</brief_title>
  <acronym>CAMAREC</acronym>
  <official_title>Prospective Multicentric Study for the Diagnostic Performance of CArdiac MAgnetic REsonance Imaging Used First for the Diagnosis of Coronary Artery Disease as the Etiology of Left Ventricular Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <brief_summary>
    <textblock>
      When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as&#xD;
      rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is&#xD;
      performed. In this situation, the investigators aim to evaluate a strategy with CMR as the&#xD;
      front line exam, and invasive coronary angiography performed only in case of ischemic scar on&#xD;
      CMR&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reduced Left Ventricular Ejection Fraction (LVEF) is estimated to be present in 3-7% of the&#xD;
      population. With a survival rate between 25-40% at 5 years after a first hospitalization,&#xD;
      prognosis of heart failure is similar to that of most cancers. Its treatment and prognosis&#xD;
      strongly depend on the etiology, and coronary artery disease is the most frequent one.&#xD;
      Identifying coronary artery disease determines care, including medical treatment (aspirin,&#xD;
      statins) and revascularization strategies (stent implantation, coronary artery bypass&#xD;
      grafting). Once an echocardiography has revealed an LV reduction, with no clear etiology at&#xD;
      clinical or echographical examination, coronary angiography is almost systematically&#xD;
      performed. But among the 260,000 invasive coronary angiographies performed each year in&#xD;
      France (all indications included), 30-60% are &quot;normal&quot; (no obstructive coronary artery).&#xD;
&#xD;
      And among patients with unexplained LV dysfunction, this rate reaches 70-74%… Thus the&#xD;
      efficiency of systematic coronary angiography is questionable for these latter. Besides,&#xD;
      angiography is invasive, and associated with multiple risks and costs.&#xD;
&#xD;
      Cardiac Magnetic Resonance Imaging (CMR) is very specific and sensitive for detecting&#xD;
      myocardial infarction. Small series concluded that a reduction of LVEF due to coronary artery&#xD;
      stenosis should have at least one myocardial scar, detected on CMR. But the available data&#xD;
      was not enough to change guidelines and clinical practice. In our retrospective study&#xD;
      performed on 305 patients, the sensibility of CMR for coronary stenosis was 96%. Furthermore,&#xD;
      CMR as a first-line exam would have avoided 71% of coronary angiography, saving 216 days of&#xD;
      hospitalization and 329.054 € (1.079€/patient). These results reinforce the previous data but&#xD;
      are not definitive.&#xD;
&#xD;
      The aim of this study is to provide a high level of evidence of the benefits and safety of a&#xD;
      strategy based on CMR as the front line exam for newly diagnosed systolic dysfunctions.&#xD;
&#xD;
      The primary objective is to evaluate the sensitivity of CMR for predicting the presence of&#xD;
      angiographically significant coronary artery stenosis in patients with reduced LVEF. The&#xD;
      primary endpoint is the sensitivity of CMR for predicting the presence of significant&#xD;
      coronary artery stenosis on coronary angiography in patients with reduced LVEF.&#xD;
&#xD;
      The objective of the economic evaluation is to estimate the incremental (or decremental) cost&#xD;
      effectiveness of using CMR first compared to coronary angiography first.&#xD;
&#xD;
      For unexplained LV dysfunction, patient will be addressed for CMR first and coronary&#xD;
      angiography within 2 weeks after (instead of systematic coronary angiography and unsystematic&#xD;
      CMR). CMR and coronary angiography will be performed in all patients. Independent committees&#xD;
      will blindly review CMRs and coronary angiographies at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">April 28, 2021</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>Sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>The primary endpoint is the sensitivity (and its 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.&#xD;
This sensitivity is the following ratio:&#xD;
Number of patients with an ischemic scar on CMR and a significant coronary artery stenosis on coronary angiography / Number of patients with a significant coronary artery stenosis on coronary angiography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the other diagnostic performances indices of CMR for the diagnosis of angiographically significant coronary artery stenosis in patients with reduced LVEF</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Sensitivity¸ specificity, positive predictive value and negative predictive value (and their 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the diagnostic performances of CMR for predicting angiographically significant coronary artery stenosis in patients with reduced LVEF requiring revascularization.</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Sensitivity¸ specificity, positive predictive value and negative predictive value (and their 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF requiring revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the concordance of CMR and coronary artery angiography in terms of coronary artery territory in patients with coronary stenosis.</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>κ concordance coefficient between CMR and coronary angiography for the diagnosis of affected myocardial territory in patients with coronary artery stenosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional value of CMR for the etiologic diagnosis of reduced LVEF including non-ischemic (LV non compaction, myocarditis …).</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Proportion of different etiological diagnosis of reduced LVEF provided only by CMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional value of CMR for the diagnosis of complications of reduced LVEF (LV thrombus mainly).</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Number of patients for whom a complication due to LVEF reduction (LV thrombus, left ventricular dys-synchrony, pre-ruptured left ventricular wall...) is provided only by CMR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional value of CMR for the decision of coronary artery revascularization.</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Proportion of patients with coronary stenosis on the coronary angiography for whom CMR change the decision of revascularization, due to the absence of myocardial viability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the reproducibility of the interpretations of CMR for ischemic cardiomyopathy.</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>κ concordance coefficient between the first interpretation of CMR (in the participating centers), and the second (by the CMR reading committee).</description>
  </secondary_outcome>
  <enrollment type="Actual">415</enrollment>
  <condition>Ischemic Cardiomyopathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients referred in one of the participating centers for the etiologic assessment of&#xD;
        an unexplained LVEF reduction will be assessed for eligibility.&#xD;
&#xD;
        A trans-thoracic echocardiography will be performed in the center at the inclusion as&#xD;
        usual, to assess LVEF and confirm the absence of obvious explanation to its reduction.&#xD;
&#xD;
        Standard biological tests (included in the standard biological investigation of dilated&#xD;
        cardiomyopathy) will be performed to exclude any contraindications to coronary angiography&#xD;
        as usual care. They are the same as those required before CMR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Left Ventricular Ejection Fraction ≤ 45% on transthoracic echocardiography&#xD;
&#xD;
          -  Informed signed consent&#xD;
&#xD;
          -  Patient having had a preliminary clinical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known significant coronary artery stenosis (history of myocardial infarction or&#xD;
             coronary artery stenosis).&#xD;
&#xD;
          -  Formal indication for coronary angiography other than LV dysfunction (typical angina,&#xD;
             acute coronary syndrome, …).&#xD;
&#xD;
          -  Obvious etiology for LV dysfunction (valvular, rhythmic…).&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Other contraindication for CMR (severe allergy to gadolinium known), or coronary&#xD;
             artery angiography.&#xD;
&#xD;
          -  First diagnosis of LVEF dysfunction &gt; 8 weeks.&#xD;
&#xD;
          -  Non covered patient by the social security, the CMU&#xD;
&#xD;
          -  Patients under guardianship, or unable to give 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>Guillaume Jondeau, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Bichat Claude-Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>cardiac MRI</keyword>
  <keyword>heart failure</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>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Left</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/NCT03231189
org study id: AOM 16181
nct id: NCT03231189
lead sponsor: 
When a patient is newly diagnosed of systolic dysfunction without obvious etiology (such as
      rhythmic, ischemic, or valvular disease), most of the time a coronary angiography is
      performed. In this situation, the investigators aim to evaluate a strategy with CMR as the
      front line exam, and invasive coronary angiography performed only in case of ischemic scar on
      CMR
Reduced Left Ventricular Ejection Fraction (LVEF) is estimated to be present in 3-7% of the
      population. With a survival rate between 25-40% at 5 years after a first hospitalization,
      prognosis of heart failure is similar to that of most cancers. Its treatment and prognosis
      strongly depend on the etiology, and coronary artery disease is the most frequent one.
      Identifying coronary artery disease determines care, including medical treatment (aspirin,
      statins) and revascularization strategies (stent implantation, coronary artery bypass
      grafting). Once an echocardiography has revealed an LV reduction, with no clear etiology at
      clinical or echographical examination, coronary angiography is almost systematically
      performed. But among the 260,000 invasive coronary angiographies performed each year in
      France (all indications included), 30-60% are "normal" (no obstructive coronary artery).

      And among patients with unexplained LV dysfunction, this rate reaches 70-74%… Thus the
      efficiency of systematic coronary angiography is questionable for these latter. Besides,
      angiography is invasive, and associated with multiple risks and costs.

      Cardiac Magnetic Resonance Imaging (CMR) is very specific and sensitive for detecting
      myocardial infarction. Small series concluded that a reduction of LVEF due to coronary artery
      stenosis should have at least one myocardial scar, detected on CMR. But the available data
      was not enough to change guidelines and clinical practice. In our retrospective study
      performed on 305 patients, the sensibility of CMR for coronary stenosis was 96%. Furthermore,
      CMR as a first-line exam would have avoided 71% of coronary angiography, saving 216 days of
      hospitalization and 329.054 € (1.079€/patient). These results reinforce the previous data but
      are not definitive.

      The aim of this study is to provide a high level of evidence of the benefits and safety of a
      strategy based on CMR as the front line exam for newly diagnosed systolic dysfunctions.

      The primary objective is to evaluate the sensitivity of CMR for predicting the presence of
      angiographically significant coronary artery stenosis in patients with reduced LVEF. The
      primary endpoint is the sensitivity of CMR for predicting the presence of significant
      coronary artery stenosis on coronary angiography in patients with reduced LVEF.

      The objective of the economic evaluation is to estimate the incremental (or decremental) cost
      effectiveness of using CMR first compared to coronary angiography first.

      For unexplained LV dysfunction, patient will be addressed for CMR first and coronary
      angiography within 2 weeks after (instead of systematic coronary angiography and unsystematic
      CMR). CMR and coronary angiography will be performed in all patients. Independent committees
      will blindly review CMRs and coronary angiographies at the end of the study.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of CMR for predicting the presence of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
time frame: up to 8 weeks
description: The primary endpoint is the sensitivity (and its 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF.
This sensitivity is the following ratio:
Number of patients with an ischemic scar on CMR and a significant coronary artery stenosis on coronary angiography / Number of patients with a significant coronary artery stenosis on coronary angiography.
measure: Evaluation of the other diagnostic performances indices of CMR for the diagnosis of angiographically significant coronary artery stenosis in patients with reduced LVEF
time frame: up to 8 weeks
description: Sensitivity¸ specificity, positive predictive value and negative predictive value (and their 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF
measure: Evaluation of the diagnostic performances of CMR for predicting angiographically significant coronary artery stenosis in patients with reduced LVEF requiring revascularization.
time frame: up to 8 weeks
description: Sensitivity¸ specificity, positive predictive value and negative predictive value (and their 95% confidence interval) of CMR for the diagnosis of significant coronary artery stenosis on coronary angiography in patients with reduced LVEF requiring revascularization
measure: Analysis of the concordance of CMR and coronary artery angiography in terms of coronary artery territory in patients with coronary stenosis.
time frame: up to 8 weeks
description: κ concordance coefficient between CMR and coronary angiography for the diagnosis of affected myocardial territory in patients with coronary artery stenosis.
measure: Additional value of CMR for the etiologic diagnosis of reduced LVEF including non-ischemic (LV non compaction, myocarditis …).
time frame: up to 8 weeks
description: Proportion of different etiological diagnosis of reduced LVEF provided only by CMR
measure: Additional value of CMR for the diagnosis of complications of reduced LVEF (LV thrombus mainly).
time frame: up to 8 weeks
description: Number of patients for whom a complication due to LVEF reduction (LV thrombus, left ventricular dys-synchrony, pre-ruptured left ventricular wall...) is provided only by CMR.
measure: Additional value of CMR for the decision of coronary artery revascularization.
time frame: up to 8 weeks
description: Proportion of patients with coronary stenosis on the coronary angiography for whom CMR change the decision of revascularization, due to the absence of myocardial viability.
measure: Evaluate the reproducibility of the interpretations of CMR for ischemic cardiomyopathy.
time frame: up to 8 weeks
description: κ concordance coefficient between the first interpretation of CMR (in the participating centers), and the second (by the CMR reading committee).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume Jondeau, MD,PhD
role: Study Director
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Cardiomyopathies
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Left
sharing ipd: No