<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/NCT04501822</url>
  </required_header>
  <id_info>
    <org_study_id>TCRC-COVID</org_study_id>
    <nct_id>NCT04501822</nct_id>
  </id_info>
  <brief_title>One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia</brief_title>
  <official_title>One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomsk National Research Medical Center of the Russian Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomsk National Research Medical Center of the Russian Academy of Sciences</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 primary objective of the study is to assess the cardiac status of COVID-19 pneumonia&#xD;
      patients during 1 year after discharge&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although COVID-19 manifests in most cases with respiratory symptoms, cardiovascular&#xD;
      abnormalities is common in hospitalized patients. Patients with cardiovascular risk factors&#xD;
      or established disease appear to have a worse prognosis. Myocardial dysfunction could be a&#xD;
      direct manifestation of COVID-19. The investigators hypothesize that subjects after COVID-19&#xD;
      pneumonia present myocardial and vascular remodeling during 1 year after discharge, even in&#xD;
      the absence of prior cardiovascular disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 19, 2021</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>Echocardiographic assessment of cardiac function</measure>
    <time_frame>up to one year</time_frame>
    <description>Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>МАССЕ</measure>
    <time_frame>up to one year</time_frame>
    <description>Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative analysis of parenchymal lung damage</measure>
    <time_frame>up to one year</time_frame>
    <description>Describe the parenchymal lung damage through a quantitative analysis with chest CT at 3 and 12 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional exercises capacity assessment</measure>
    <time_frame>up to one year</time_frame>
    <description>Six-min walk test at 3 and 12 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of renal function</measure>
    <time_frame>up to one year</time_frame>
    <description>Measure of creatinine clearance at 3 and 12 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of inflammation</measure>
    <time_frame>up to one year</time_frame>
    <description>Analysis for C-reactive protein at 3 and 12 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of coagulation abnormality</measure>
    <time_frame>up to one year</time_frame>
    <description>Analysis for activated clotting time at 3 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of quality of life in first year after discharge</measure>
    <time_frame>up to one year</time_frame>
    <description>Assessment of the Short Form Health Survey (SF36) at 3 and 12 months after discharge</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">380</enrollment>
  <condition>Covid19</condition>
  <condition>Cardiac Complication</condition>
  <arm_group>
    <arm_group_label>Covid19 pneumonia patients</arm_group_label>
    <description>The study includes men and women ≥18 years old with documented COVID-19 pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Evaluation of clinical, instrumental and laboratory diagnostics tests</intervention_name>
    <description>During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests</description>
    <arm_group_label>Covid19 pneumonia patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study includes men and women ≥18 years old with documented COVID-19 pneumonia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients with documented COVID-19 pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer&#xD;
&#xD;
          -  Impossible to follow up&#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_official>
    <last_name>Elena Yaroslavskaya, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tyumen Cardiology Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science</name>
      <address>
        <city>Tyumen</city>
        <zip>625026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid19</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04501822/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04501822
org study id: TCRC-COVID
nct id: NCT04501822
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia
      patients during 1 year after discharge
Although COVID-19 manifests in most cases with respiratory symptoms, cardiovascular
      abnormalities is common in hospitalized patients. Patients with cardiovascular risk factors
      or established disease appear to have a worse prognosis. Myocardial dysfunction could be a
      direct manifestation of COVID-19. The investigators hypothesize that subjects after COVID-19
      pneumonia present myocardial and vascular remodeling during 1 year after discharge, even in
      the absence of prior cardiovascular disease.
observational model: Cohort
time perspective: Prospective
measure: Echocardiographic assessment of cardiac function
time frame: up to one year
description: Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge
measure: МАССЕ
time frame: up to one year
description: Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge
measure: Quantitative analysis of parenchymal lung damage
time frame: up to one year
description: Describe the parenchymal lung damage through a quantitative analysis with chest CT at 3 and 12 months after discharge
measure: Functional exercises capacity assessment
time frame: up to one year
description: Six-min walk test at 3 and 12 months after discharge
measure: Evaluation of renal function
time frame: up to one year
description: Measure of creatinine clearance at 3 and 12 months after discharge
measure: Evaluation of inflammation
time frame: up to one year
description: Analysis for C-reactive protein at 3 and 12 months after discharge
measure: Evaluation of coagulation abnormality
time frame: up to one year
description: Analysis for activated clotting time at 3 and 12 months
measure: Evaluation of quality of life in first year after discharge
time frame: up to one year
description: Assessment of the Short Form Health Survey (SF36) at 3 and 12 months after discharge
arm group label: Covid19 pneumonia patients
description: The study includes men and women ≥18 years old with documented COVID-19 pneumonia
intervention type: Diagnostic Test
intervention name: Evaluation of clinical, instrumental and laboratory diagnostics tests
description: During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests
arm group label: Covid19 pneumonia patients
Whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Yaroslavskaya, PhD
role: Principal Investigator
affiliation: Tyumen Cardiology Research Center
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: No
provided document: 