<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/NCT04452630</url>
  </required_header>
  <id_info>
    <org_study_id>2020-36</org_study_id>
    <nct_id>NCT04452630</nct_id>
  </id_info>
  <brief_title>Cardiovascular Consequences After COVID-19</brief_title>
  <official_title>The CardioPostCovid Study: Cardiovascular Consequences After COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      The occurrence of cardiovascular complications in SARS-CoV-2 infections appears to be more&#xD;
      frequent than in other viral respiratory infections, probably due to a singular&#xD;
      pathophysiology of this coronavirus.&#xD;
&#xD;
      The lack of characterization of cardiovascular damages linked to Covid-19 could have medium&#xD;
      and long-term consequences on the prognosis of patients. This problematic could lead to a&#xD;
      second major public health problem linked to Covid-19 and it is therefore crucial to keep&#xD;
      monitoring and screening patients at risk.&#xD;
&#xD;
      In this context of emerging infectious diseases, of poorly characterized cardiovascular&#xD;
      damages during infection and of absence of data on the long-term evolution of the infection,&#xD;
      the investigators propose to carry out a prospective and observational cohort study focused&#xD;
      on the evaluation and the systematic cardiovascular follow up of patients who survived an&#xD;
      episode of Covid-19, regardless of their cardiovascular profiles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 23, 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>Presence of at least one clinical, biological and/or imaging cardiovascular anomaly within 1 month of recovering</measure>
    <time_frame>1 month</time_frame>
    <description>Describe clinical, biological and imaging cardiovascular data 1 month after recovery from an episode of Covid-19</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cardiovascular Consequences After an Episode of COVID 19</condition>
  <arm_group>
    <arm_group_label>Covid 19 Patients</arm_group_label>
    <description>patients having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal RT-PCR test for SARS-Cov-2 and considered recovered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infectious Disease and Cardiology Clinical Consultations</intervention_name>
    <description>Infectious Diseases and Cardiology Clinical Consultations at 1 month and 12 months of recovery from an episode of Covid-19</description>
    <arm_group_label>Covid 19 Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients can be enrolled in this study if they survived to an episode of Covid-19, whether&#xD;
        they were hospitalized or not. They must have been diagnosed Covid19 positive according to&#xD;
        international recommendations between January 24, 2020 (date of the first case declared in&#xD;
        mainland France) and June 30, 2020. They will be offered to participate to the study during&#xD;
        the systematic consultations set up at the Nord Hospital for follow-up patients who have&#xD;
        been infected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All adults affiliated to social security attending the post-Covid follow-up consultation,&#xD;
        having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal&#xD;
        RT-PCR test for SARS-Cov-2 and considered recovered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years old&#xD;
&#xD;
          -  Major under guardianship or curatorship&#xD;
&#xD;
          -  Absence of non-opposition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Franck THUNY, MD</last_name>
    <email>franck.thuny@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck THUNY, MD</last_name>
      <email>franck.thuny@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 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>COVID-19</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/NCT04452630
org study id: 2020-36
nct id: NCT04452630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The occurrence of cardiovascular complications in SARS-CoV-2 infections appears to be more
      frequent than in other viral respiratory infections, probably due to a singular
      pathophysiology of this coronavirus.

      The lack of characterization of cardiovascular damages linked to Covid-19 could have medium
      and long-term consequences on the prognosis of patients. This problematic could lead to a
      second major public health problem linked to Covid-19 and it is therefore crucial to keep
      monitoring and screening patients at risk.

      In this context of emerging infectious diseases, of poorly characterized cardiovascular
      damages during infection and of absence of data on the long-term evolution of the infection,
      the investigators propose to carry out a prospective and observational cohort study focused
      on the evaluation and the systematic cardiovascular follow up of patients who survived an
      episode of Covid-19, regardless of their cardiovascular profiles.
observational model: Cohort
time perspective: Prospective
measure: Presence of at least one clinical, biological and/or imaging cardiovascular anomaly within 1 month of recovering
time frame: 1 month
description: Describe clinical, biological and imaging cardiovascular data 1 month after recovery from an episode of Covid-19
arm group label: Covid 19 Patients
description: patients having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal RT-PCR test for SARS-Cov-2 and considered recovered.
intervention type: Other
intervention name: Infectious Disease and Cardiology Clinical Consultations
description: Infectious Diseases and Cardiology Clinical Consultations at 1 month and 12 months of recovery from an episode of Covid-19
arm group label: Covid 19 Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franck THUNY, MD
email: franck.thuny@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No