xml: <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/NCT05967026</url>
    </required_header>
    <id_info>
      <org_study_id>2023PI071</org_study_id>
      <nct_id>NCT05967026</nct_id>
    </id_info>
    <brief_title>Characterization of Myocardial Infarction Scar Using Magnetic Resonance Imaging</brief_title>
    <acronym>MI-SCAR-MRI</acronym>
    <official_title>Characterization of Myocardial Infarction Scar Using Magnetic Resonance Imaging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Hospital, Nancy, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Central Hospital, Nancy, France</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this monocentric observationnal study is to describe the characteristics of the&#xD;
        myocardial infarction scar in terms of transmurality in residual LVEF&gt;35% patients.&#xD;
  &#xD;
        The primary objective is to determine the frequency of the criterion &quot;intramural scar&#xD;
        ≥1.47cm2&quot; (measured by MRI) in patients who presented with myocardial infarction with&#xD;
        residual LVEF≥35%.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">August 2023</completion_date>
    <primary_completion_date type="Anticipated">July 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Intramural scar surface in cm²</measure>
      <time_frame>6 weeks after myocardial infarction</time_frame>
      <description>Intramural scar surface in cm²&gt;1.47cm²</description>
    </primary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Myocardial Infarction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with a history of acute coronary syndrome prior to inclusion and having undergone&#xD;
          cardiac MRI and LVEF &gt;35% measured at least 6 weeks post-IDM by echocardiography or MRI&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years ;&#xD;
  &#xD;
            -  History of acute coronary syndrome prior to inclusion and having undergone cardiac&#xD;
               MRI;&#xD;
  &#xD;
            -  LVEF &gt;35% measured at least 6 weeks post-IDM by echocardiography or MRI;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Patient with an implantable cardiac device (implantable cardioverter defibrillator or&#xD;
          pacemaker) prior to MRI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CHU of Nancy</name>
        <address>
          <city>Nancy</city>
          <zip>54000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
      <investigator_full_name>HAMMACHE Nefissa</investigator_full_name>
      <investigator_title>Residant in Cardiology Unit</investigator_title>
    </responsible_party>
    <keyword>cardiac magnetic resonance</keyword>
    <keyword>sudden cardiac death</keyword>
    <keyword>risk stratification</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967026
  org study id: 2023PI071
  nct id: NCT05967026
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this monocentric observationnal study is to describe the characteristics of the
        myocardial infarction scar in terms of transmurality in residual LVEF>35% patients.
  
        The primary objective is to determine the frequency of the criterion "intramural scar
        ≥1.47cm2" (measured by MRI) in patients who presented with myocardial infarction with
        residual LVEF≥35%.
  observational model: Cohort
  time perspective: Retrospective
  measure: Intramural scar surface in cm²
  time frame: 6 weeks after myocardial infarction
  description: Intramural scar surface in cm²>1.47cm²
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Central Hospital, Nancy, France
  investigator full name: HAMMACHE Nefissa
  investigator title: Residant in Cardiology Unit
  mesh term: Myocardial Infarction
  mesh term: Infarction