<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/NCT02967965</url>
  </required_header>
  <id_info>
    <org_study_id>CARIM</org_study_id>
    <nct_id>NCT02967965</nct_id>
  </id_info>
  <brief_title>CARdioprotection in Myocardial Infarction</brief_title>
  <acronym>CARIM</acronym>
  <official_title>CARIM Cohort (CARdioprotection in Myocardial Infarction)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EZUS-LYON 1</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EZUS-LYON 1</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and&#xD;
      undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and&#xD;
      younger than 90 years with onset of chest pain of less than 12 hours who need a primary&#xD;
      percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be&#xD;
      recruited.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the setting of research in ischemic cardiomyopathy, the CARIM cohort aims to meet the&#xD;
      expectation and strategy of Aviesan (Alliance nationale pour les sciences de la VIE et de la&#xD;
      SANté) since it will address the underlying pathophysiology of the determinants of MI injury&#xD;
      and its impact on follow-up, in addition with the potential confounding clinical and&#xD;
      biological factors. Therefore, CARIM cohort will offer a great opportunity of describing the&#xD;
      interactions between myocardial infarction and surrounding environment (clinical, social and&#xD;
      professional). This cohort will use complementary state of the art approaches (cardiac&#xD;
      imaging including Cardiovascular Magnetic Resonance and echocardiography, biomarkers,&#xD;
      proteomic, genetic and pharmacogenetics) with strong interactions between the different&#xD;
      partners. Therefore CARIM cohort should help to obtain a modeling of the determinants of the&#xD;
      MI size.&#xD;
&#xD;
      The investigators expect that CARIM cohort will provide new imaging or biological markers&#xD;
      that may bring early information regarding the severity of lethal reperfusion injury.&#xD;
&#xD;
      By optimizing the knowledge on infarct injury in addition with a 5-year clinical and&#xD;
      echographic follow-up, this cohort will better stratify the prognosis after MI and will&#xD;
      therefore give new insights in identifying patients at higher risk of left ventricular&#xD;
      remodeling and subsequent heart failure. It will therefore help and emphasize prevention&#xD;
      messages and patients' education. The aim is to translate this information directly into&#xD;
      patient care by using the science generated by this project to develop new management&#xD;
      guidelines and novel clinical tools (confounder-annotated database, imaging and biological&#xD;
      biomarkers). This cohort may have additional impact in patient care by adapting the treatment&#xD;
      to patient-related confounders (age, diabetes...), genetic polymorphisms and thus&#xD;
      personalizing health care to individuals.&#xD;
&#xD;
      3.2 MAIN OBJECTIVE&#xD;
&#xD;
      The investigators main objective is to create a prospective cohort of 2,000 patients (CARIM&#xD;
      cohort) with a first myocardial infarction and undergoing reperfusion therapy in order to&#xD;
      evaluate the impact of patient-related confounders on myocardial infarct size and LRI in&#xD;
      order to further design a modeling of myocardial infarct size.&#xD;
&#xD;
      For this purpose, CARIM cohort will be associated with the creation of a non-invasive cardiac&#xD;
      imaging data-bank (MRI and echocardiography) in addition with a large bio-bank relying on&#xD;
      existing biological certified platforms (i.e. BRC network).&#xD;
&#xD;
      This cohort will provide a population of first acute MI, optimally characterized in terms of&#xD;
      comprehensive clinical and angiography phenotype, specifically characterized by CMR in terms&#xD;
      of infarct size and LRI and by echocardiography in terms of myocardial regional function and&#xD;
      left ventricular remodeling.&#xD;
&#xD;
      3.3 SECONDARY OBJECTIVES&#xD;
&#xD;
        1. Evaluate the specific impact of myocardial infarct injury on myocardial regional&#xD;
           function and left ventricular remodeling (defined by an increase in LV end-diastolic&#xD;
           volume &gt; 20% between week 1 and month 12 post-MI by echocardiography).&#xD;
&#xD;
        2. Evaluate the power of the myocardial infarct injury in predicting cardiovascular events&#xD;
           (rehospitalizations, reinfarction, occurrence of HF, transplantation, arrhythmias,&#xD;
           death) in a 5-year patient follow-up.&#xD;
&#xD;
        3. Test the value of established or newly identified plasma/serum biomarkers to identify&#xD;
           LRI and to predict post-MI LV remodeling and progression towards CHF during a 5 year&#xD;
           follow-up.&#xD;
&#xD;
        4. This cohort aims ultimately at defining the profile of the MI patient population to be&#xD;
           used for future trials implementing new protective interventions targeting LRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Determinants of myocardial infarct injury</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Myocardial Infarct</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Clinical Evaluation, Coronarography, Imagery by MRI, Echocardiography and Biological samples will be collected for each patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Imagery</intervention_name>
    <description>MRI at year 3</description>
    <arm_group_label>Cohort</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      J2-4: 63 mL (3 dry tubes ; 2 citrate tubes and 4 tubes with EDTA, with 2 for DNA isolation)&#xD;
      M6: 28 mL (2 dry tube, 1 citrate tube and 1 tube with EDTA) M12: 21 mL (1 dry tube, 1 citrate&#xD;
      tube and 1 tube with EDTA) Optional: In centers adequately equipped for management of blood&#xD;
      samples in the catheterization laboratory, blood samples will be also taken at JO, before and&#xD;
      4 hours after reperfusion (14 ml each: 1 dry tube and 1 tube with EDTA) after obtention of&#xD;
      the agreement of the patient to be included in the cohort CARIM.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and&#xD;
        undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and&#xD;
        younger than 90 years with onset of chest pain of less than 12 hours who need a primary&#xD;
        percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be&#xD;
        recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any patient hospitalized in the cardiology department of the participating centers&#xD;
&#xD;
          -  Who have signed the Informed Consent Form.&#xD;
&#xD;
          -  Patient having health insurance.&#xD;
&#xD;
          -  Requiring PCI for reperfusion.&#xD;
&#xD;
          -  With a diagnosis of a first MI.&#xD;
&#xD;
          -  With ST segment elevation and/or Q wave at admission.&#xD;
&#xD;
          -  With troponin elevation.&#xD;
&#xD;
          -  Seen within the first 12 hours after symptom onset.&#xD;
&#xD;
          -  Aged between 18 and 90 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient.&#xD;
&#xD;
          -  In case of poor echogenicity, the participation of the patient will be stopped.&#xD;
&#xD;
          -  Patient with diagnosis of previous MI, or hypertrophic or dilated cardiomyopathy, or&#xD;
             significant valvular heart disease, or chronic atrial fibrillation, or pace maker or&#xD;
             any permanent implanted device susceptible to interfere with LV remodeling.&#xD;
&#xD;
          -  Patient with preexisting heart failure.&#xD;
&#xD;
          -  Patient with any previous cardiac surgery.&#xD;
&#xD;
          -  Patient with previous chemotherapy susceptible to induce LV remodeling&#xD;
             (anthracyclines).&#xD;
&#xD;
          -  Patient with an associated short-time life-threatening disease.&#xD;
&#xD;
          -  Pregnant or breast-feeding patient.&#xD;
&#xD;
          -  Contra-indication to MRI (claustrophobia, pacemaker or any other metallic implants,&#xD;
             creatinin clearance &lt; 30mL/min/1.73m2 MDRD).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Genevieve DERUMEAUX, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU de Tours</name>
      <address>
        <city>Tours</city>
        <state>Indre Et Loire</state>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Mondor</name>
      <address>
        <city>Creteil</city>
        <state>Rhône</state>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clinical confounders</keyword>
  <keyword>myocardial infarction size</keyword>
  <keyword>determinants of myocardial infarct injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT02967965
org study id: CARIM
nct id: NCT02967965
lead sponsor: 
has dmc: No
CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and
      undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and
      younger than 90 years with onset of chest pain of less than 12 hours who need a primary
      percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be
      recruited.
In the setting of research in ischemic cardiomyopathy, the CARIM cohort aims to meet the
      expectation and strategy of Aviesan (Alliance nationale pour les sciences de la VIE et de la
      SANté) since it will address the underlying pathophysiology of the determinants of MI injury
      and its impact on follow-up, in addition with the potential confounding clinical and
      biological factors. Therefore, CARIM cohort will offer a great opportunity of describing the
      interactions between myocardial infarction and surrounding environment (clinical, social and
      professional). This cohort will use complementary state of the art approaches (cardiac
      imaging including Cardiovascular Magnetic Resonance and echocardiography, biomarkers,
      proteomic, genetic and pharmacogenetics) with strong interactions between the different
      partners. Therefore CARIM cohort should help to obtain a modeling of the determinants of the
      MI size.

      The investigators expect that CARIM cohort will provide new imaging or biological markers
      that may bring early information regarding the severity of lethal reperfusion injury.

      By optimizing the knowledge on infarct injury in addition with a 5-year clinical and
      echographic follow-up, this cohort will better stratify the prognosis after MI and will
      therefore give new insights in identifying patients at higher risk of left ventricular
      remodeling and subsequent heart failure. It will therefore help and emphasize prevention
      messages and patients' education. The aim is to translate this information directly into
      patient care by using the science generated by this project to develop new management
      guidelines and novel clinical tools (confounder-annotated database, imaging and biological
      biomarkers). This cohort may have additional impact in patient care by adapting the treatment
      to patient-related confounders (age, diabetes...), genetic polymorphisms and thus
      personalizing health care to individuals.

      3.2 MAIN OBJECTIVE

      The investigators main objective is to create a prospective cohort of 2,000 patients (CARIM
      cohort) with a first myocardial infarction and undergoing reperfusion therapy in order to
      evaluate the impact of patient-related confounders on myocardial infarct size and LRI in
      order to further design a modeling of myocardial infarct size.

      For this purpose, CARIM cohort will be associated with the creation of a non-invasive cardiac
      imaging data-bank (MRI and echocardiography) in addition with a large bio-bank relying on
      existing biological certified platforms (i.e. BRC network).

      This cohort will provide a population of first acute MI, optimally characterized in terms of
      comprehensive clinical and angiography phenotype, specifically characterized by CMR in terms
      of infarct size and LRI and by echocardiography in terms of myocardial regional function and
      left ventricular remodeling.

      3.3 SECONDARY OBJECTIVES

        1. Evaluate the specific impact of myocardial infarct injury on myocardial regional
           function and left ventricular remodeling (defined by an increase in LV end-diastolic
           volume > 20% between week 1 and month 12 post-MI by echocardiography).

        2. Evaluate the power of the myocardial infarct injury in predicting cardiovascular events
           (rehospitalizations, reinfarction, occurrence of HF, transplantation, arrhythmias,
           death) in a 5-year patient follow-up.

        3. Test the value of established or newly identified plasma/serum biomarkers to identify
           LRI and to predict post-MI LV remodeling and progression towards CHF during a 5 year
           follow-up.

        4. This cohort aims ultimately at defining the profile of the MI patient population to be
           used for future trials implementing new protective interventions targeting LRI.
observational model: Cohort
time perspective: Prospective
measure: Determinants of myocardial infarct injury
time frame: 5 years
arm group label: Cohort
description: Clinical Evaluation, Coronarography, Imagery by MRI, Echocardiography and Biological samples will be collected for each patient.
intervention type: Other
intervention name: Imagery
description: MRI at year 3
arm group label: Cohort
other name: MRI
J2-4: 63 mL (3 dry tubes ; 2 citrate tubes and 4 tubes with EDTA, with 2 for DNA isolation)
      M6: 28 mL (2 dry tube, 1 citrate tube and 1 tube with EDTA) M12: 21 mL (1 dry tube, 1 citrate
      tube and 1 tube with EDTA) Optional: In centers adequately equipped for management of blood
      samples in the catheterization laboratory, blood samples will be also taken at JO, before and
      4 hours after reperfusion (14 ml each: 1 dry tube and 1 tube with EDTA) after obtention of
      the agreement of the patient to be included in the cohort CARIM.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Genevieve DERUMEAUX, Professor
role: Principal Investigator
affiliation: APHP
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No