<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/NCT04413071</url>
  </required_header>
  <id_info>
    <org_study_id>CCC_2020</org_study_id>
    <nct_id>NCT04413071</nct_id>
  </id_info>
  <brief_title>Cardiac COVID-19 Health Care Workers</brief_title>
  <acronym>CCC</acronym>
  <official_title>Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AORTICA Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Salamanca University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigación Biomédica de Salamanca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AORTICA Group</source>
  <oversight_info>
    <has_dmc>Yes</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 study will analyze the prevalence of cardiac involvement of health care workers from the&#xD;
      University Hospital of Salamanca (HUSA) who have overcome SARS-CoV-2 infection. Participants&#xD;
      will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR)&#xD;
      and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most people infected with SARS-CoV-2 experience mild, self-limiting symptoms that have been&#xD;
      managed in an outpatient setting and therefore have not undergone routine cardiac evaluation&#xD;
      with EKG or cardiac imaging test. Similarly, although the emphasis has been placed on&#xD;
      evaluating patients with severe respiratory symptoms, most of these patients have also not&#xD;
      undergone cardiac imaging tests and; therefore, in both scenarios, possible myocarditis has&#xD;
      not routinely evaluated.&#xD;
&#xD;
      The present study is designed to characterize cardiac involvement in individuals who have&#xD;
      overcome the SARS-CoV-2 infection.&#xD;
&#xD;
      For that aim, the study is designed as an observational cross-sectional study. The target&#xD;
      population are HUSA healthcare workers who have overcome SARS-CoV-2 infection, either&#xD;
      symptomatic or asymptomatic, either having required hospital admission or not. Participants&#xD;
      will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR)&#xD;
      and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.&#xD;
&#xD;
      Main objectives of the study are to address the prevalence of myocardial damage suggestive of&#xD;
      myocarditis and to address the prevalence of pericarditis in HUSA health care workers; both&#xD;
      related to the systemic immune response to SARS-CoV-2 infection. As secondary objectives the&#xD;
      study will further address other cardiac affections including: rhythm or conduction&#xD;
      disorders, ischemic heart disease, dilatation of the right chambers, valve disease and will&#xD;
      analyze the relationship between humoral and cellular immunity and the presence of cardiac&#xD;
      involvement, and the genetic susceptibility in the development of cardiac involvement after&#xD;
      SARS-CoV-2 infection.&#xD;
&#xD;
      The study will recruit 141 participants: 47 symptomatic hospitalized health care workers, 47&#xD;
      asymptomatic non-hospitalized health care workers, 47 asymptomatic health care workers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 12, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Myocarditis</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pericarditis</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of pericarditis assessed by clinical criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of atrial fibrillation on EKG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ischemic heart disease</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of ischemic heart disease assessed by cardiac magnetic resonance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dilatation of right heart chambers</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valvular hear disease</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of valvular heart disease assessed by cardiac magnetic resonance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rhythm disorders</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Prevalence of prolonged QT interval on EKG</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">142</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>COVID-19</condition>
  <condition>Coronavirus</condition>
  <condition>Cardiac Magnetic Resonance</condition>
  <condition>Myocarditis</condition>
  <condition>Cardiac Anomaly</condition>
  <arm_group>
    <arm_group_label>Health care workers</arm_group_label>
    <description>Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passed infection of SARS-CoV-2</intervention_name>
    <description>This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.</description>
    <arm_group_label>Health care workers</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Analysis of immunity polymorphisms including low-resolution HLA typing and genotyping of KIR&#xD;
      genes&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The target population are Salamanca´s healthcare workers who have overcome SARS-CoV-2&#xD;
        infection, either symptomatic or asymptomatic, either having required hospital admission or&#xD;
        not.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have overcome the SARS-CoV-2 infection meeting any of the following criteria (i)&#xD;
             positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of&#xD;
             a specimen collected on a nasopharyngeal swab followed by a second negative RT-PCR and&#xD;
             at least 14 days from this negative RT-PCR; (ii) presence of IgM antibodies and&#xD;
             negative RT-PCR after the antibody assessment; (iii) presence of neutralizing IgG&#xD;
             antibodies and absence of IgM.&#xD;
&#xD;
          -  stable clinical situation, which allows performing a CMR.&#xD;
&#xD;
          -  signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of IgM antibodies without negative subsequent RT-PCR.&#xD;
&#xD;
          -  Contraindications to perform RMC: (i) gadolinium allergy, (ii) presence of metallic&#xD;
             material in the body, such as plates, screws, incompatible pacemakers, etc. (iii)&#xD;
             claustrophobia, (iv) severe kidney failure, (v) severe liver failure, (vi) sickle cell&#xD;
             anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>71 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Salamanca University Hospital</investigator_affiliation>
    <investigator_full_name>Pedro L Sanchez</investigator_full_name>
    <investigator_title>Director of the Cardiology Department, Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Myocarditis</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04413071
org study id: CCC_2020
nct id: NCT04413071
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will analyze the prevalence of cardiac involvement of health care workers from the
      University Hospital of Salamanca (HUSA) who have overcome SARS-CoV-2 infection. Participants
      will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR)
      and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.
Most people infected with SARS-CoV-2 experience mild, self-limiting symptoms that have been
      managed in an outpatient setting and therefore have not undergone routine cardiac evaluation
      with EKG or cardiac imaging test. Similarly, although the emphasis has been placed on
      evaluating patients with severe respiratory symptoms, most of these patients have also not
      undergone cardiac imaging tests and; therefore, in both scenarios, possible myocarditis has
      not routinely evaluated.

      The present study is designed to characterize cardiac involvement in individuals who have
      overcome the SARS-CoV-2 infection.

      For that aim, the study is designed as an observational cross-sectional study. The target
      population are HUSA healthcare workers who have overcome SARS-CoV-2 infection, either
      symptomatic or asymptomatic, either having required hospital admission or not. Participants
      will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR)
      and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.

      Main objectives of the study are to address the prevalence of myocardial damage suggestive of
      myocarditis and to address the prevalence of pericarditis in HUSA health care workers; both
      related to the systemic immune response to SARS-CoV-2 infection. As secondary objectives the
      study will further address other cardiac affections including: rhythm or conduction
      disorders, ischemic heart disease, dilatation of the right chambers, valve disease and will
      analyze the relationship between humoral and cellular immunity and the presence of cardiac
      involvement, and the genetic susceptibility in the development of cardiac involvement after
      SARS-CoV-2 infection.

      The study will recruit 141 participants: 47 symptomatic hospitalized health care workers, 47
      asymptomatic non-hospitalized health care workers, 47 asymptomatic health care workers
observational model: Cohort
time perspective: Cross-Sectional
measure: Myocarditis
time frame: up to 3 months
description: Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
measure: Pericarditis
time frame: up to 3 months
description: Prevalence of pericarditis assessed by clinical criteria
measure: Atrial fibrillation
time frame: up to 3 months
description: Prevalence of atrial fibrillation on EKG
measure: Ischemic heart disease
time frame: up to 3 months
description: Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
measure: Dilatation of right heart chambers
time frame: up to 3 months
description: Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
measure: Valvular hear disease
time frame: up to 3 months
description: Prevalence of valvular heart disease assessed by cardiac magnetic resonance
measure: Rhythm disorders
time frame: up to 3 months
description: Prevalence of prolonged QT interval on EKG
arm group label: Health care workers
description: Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.
intervention type: Other
intervention name: Passed infection of SARS-CoV-2
description: This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
arm group label: Health care workers
Analysis of immunity polymorphisms including low-resolution HLA typing and genotyping of KIR
      genes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 71 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Salamanca University Hospital
investigator full name: Pedro L Sanchez
investigator title: Director of the Cardiology Department, Professor of Medicine
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Myocarditis
mesh term: Heart Defects, Congenital
sharing ipd: Undecided