<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/NCT04498091</url>
  </required_header>
  <id_info>
    <org_study_id>Zeller AOIc 2020</org_study_id>
    <nct_id>NCT04498091</nct_id>
  </id_info>
  <brief_title>EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19</brief_title>
  <acronym>EPI CV COVID</acronym>
  <official_title>EPIdemiological Approaches to the Cardiovascular Consequences of 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>
      The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as&#xD;
      coronary artery disease, which significantly increase the risk of mortality in patients&#xD;
      infected with SARS-CoV2. Investigators have recently studied the complex links between&#xD;
      respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many&#xD;
      respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need&#xD;
      in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the&#xD;
      investigators investigated whether COVID-19-related sepsis and/or respiratory failure could&#xD;
      be an underlying mechanism of MI2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Characterizing type 2 myocardial infarction associated with CoV-2 SARS infection</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <description>Type 2 MI with COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <description>Type 2 without COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <description>Type 2 MI with pneumonia without COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D</arm_group_label>
    <description>Type 2 MI without pneumonia and without COVID-19</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>
    <arm_group_label>C</arm_group_label>
    <arm_group_label>D</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>
    <arm_group_label>C</arm_group_label>
    <arm_group_label>D</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with acute type 2 MI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without&#xD;
             pneumonia&#xD;
&#xD;
          -  patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without&#xD;
             COVID 19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>August 2020</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>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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>Myocardial Infarction</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/NCT04498091
org study id: Zeller AOIc 2020
nct id: NCT04498091
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as
      coronary artery disease, which significantly increase the risk of mortality in patients
      infected with SARS-CoV2. Investigators have recently studied the complex links between
      respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many
      respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need
      in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the
      investigators investigated whether COVID-19-related sepsis and/or respiratory failure could
      be an underlying mechanism of MI2.
observational model: Cohort
time perspective: Prospective
measure: Characterizing type 2 myocardial infarction associated with CoV-2 SARS infection
time frame: Through study completion, an average of 1 year
arm group label: A
description: Type 2 MI with COVID-19
arm group label: B
description: Type 2 without COVID-19
arm group label: C
description: Type 2 MI with pneumonia without COVID-19
arm group label: D
description: Type 2 MI without pneumonia and without COVID-19
intervention type: Biological
intervention name: Biological data
description: Biological data
arm group label: A
arm group label: B
arm group label: C
arm group label: D
intervention type: Other
intervention name: Clinical data
description: Clinical data
arm group label: A
arm group label: B
arm group label: C
arm group label: D
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: Myocardial Infarction
mesh term: Infarction