<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/NCT04455347</url>
  </required_header>
  <id_info>
    <org_study_id>HJ-20-CARDOVID</org_study_id>
    <nct_id>NCT04455347</nct_id>
  </id_info>
  <brief_title>Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked</brief_title>
  <acronym>CARDOVID</acronym>
  <official_title>Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imagine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imagine Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or&#xD;
      CT scan including cardiac functional evaluation and myocardial tissue characterization of&#xD;
      COVID_19 related disease in pediatric patients with cardiac involvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Imaging data at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Description of imaging data from MRI ans CT scan and associated clinical data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Imagine data at Follow-up</measure>
    <time_frame>During the 2 years follow-up period</time_frame>
    <description>Description of imaging data from MRI ans CT scan and associated clinical data.</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>COVID-19 Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a probable or a proven diagnosis of COVID 19 admitted for systemic acute&#xD;
        inflammation and cardiac symptoms (cardiogenic shock or chest pain or clinical suspicion of&#xD;
        acute myocarditis or left ventricular ejection fraction)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with cardiac MRI or cardiac CT scan or thoracic CT scan admitted for acute&#xD;
             inflammatory syndrome and cardiac compromise&#xD;
&#xD;
          2. Patient with PCR or antibodies test for COVID 19 (positive of negative)&#xD;
&#xD;
          3. Patient or parents of minor patients informed about collection of personal data for&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient or parents refusing personal data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesca Raimondi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Necker</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesca Raimondi, MD</last_name>
    <phone>+33171396537</phone>
    <email>francesca.raimondi@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yasmine Ainouz, MD</last_name>
    <phone>+33658976496</phone>
    <email>yasmine.ainouz@institutimagine.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Necker</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesca Raimondi</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19 Infection</keyword>
  <keyword>Children</keyword>
  <keyword>Acute Myocarditis</keyword>
  <keyword>Kawasaki-like-syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Inflammation</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/NCT04455347
org study id: HJ-20-CARDOVID
nct id: NCT04455347
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or
      CT scan including cardiac functional evaluation and myocardial tissue characterization of
      COVID_19 related disease in pediatric patients with cardiac involvement.
observational model: Cohort
time perspective: Prospective
measure: Imaging data at Baseline
time frame: Baseline
description: Description of imaging data from MRI ans CT scan and associated clinical data.
measure: Imagine data at Follow-up
time frame: During the 2 years follow-up period
description: Description of imaging data from MRI ans CT scan and associated clinical data.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Years
healthy volunteers: No
last name: Francesca Raimondi, MD
role: Principal Investigator
affiliation: Hôpital Necker
last name: Francesca Raimondi, MD
phone: +33171396537
email: francesca.raimondi@aphp.fr
last name: Yasmine Ainouz, MD
phone: +33658976496
email: yasmine.ainouz@institutimagine.org
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Inflammation