<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/NCT04498065</url>
  </required_header>
  <id_info>
    <org_study_id>COTTIN AOIc 2020</org_study_id>
    <nct_id>NCT04498065</nct_id>
  </id_info>
  <brief_title>MYocardial DOmmages Related to COVID-19</brief_title>
  <acronym>DOMY COVID</acronym>
  <official_title>MYocardial DOmmages Related to COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among&#xD;
      patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial&#xD;
      inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as&#xD;
      myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to&#xD;
      Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation&#xD;
      of cardiac biomarkers could be linked to the occurrence of myocarditis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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>characterize the myocardial damage associated with CoV-2 SARS infection</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Myocardtitis diagnosis in patients COVID+ and troponin+</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">273</enrollment>
  <condition>Covid19</condition>
  <condition>Non Ischemic Myocardial Injury</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Myocarditis</condition>
  <condition>Troponin Elevation</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <description>COVID positive and Troponin positive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <description>COVID positive and Troponin negative</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological data</intervention_name>
    <description>Biological data</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical data</intervention_name>
    <description>Clinical data</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to CHU Dijon Bourgogne for COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 positive patient hospitalized &lt; 72 h after symptoms onset with troponin&#xD;
             assessement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients hospitalized &gt; 72h after symptom onset&#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 Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Myocarditis</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT04498065
org study id: COTTIN AOIc 2020
nct id: NCT04498065
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among
      patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial
      inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as
      myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to
      Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation
      of cardiac biomarkers could be linked to the occurrence of myocarditis.
observational model: Cohort
time perspective: Prospective
measure: characterize the myocardial damage associated with CoV-2 SARS infection
time frame: Through study completion, an average of 2 years
description: Myocardtitis diagnosis in patients COVID+ and troponin+
arm group label: A
description: COVID positive and Troponin positive
arm group label: B
description: COVID positive and Troponin negative
intervention type: Biological
intervention name: Biological data
description: Biological data
arm group label: A
arm group label: B
intervention type: Other
intervention name: Clinical data
description: Clinical data
arm group label: A
arm group label: B
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: Sponsor
mesh term: COVID-19
mesh term: Myocardial Infarction
mesh term: Myocarditis
mesh term: Infarction