Skip to main content
OpenTrials
Completed

NCT Number: NCT04413071

Cardiac COVID-19 Health Care Workers

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have overcome the SARS-CoV-2 infection meeting any of the following criteria (i) positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab followed by a second negative RT-PCR and at least 14 days from this negative RT-PCR; (ii) presence of IgM antibodies and negative RT-PCR after the antibody assessment; (iii) presence of neutralizing IgG antibodies and absence of IgM.
  • stable clinical situation, which allows performing a CMR.
  • signature of informed consent.

Exclusion criteria

  • Presence of IgM antibodies without negative subsequent RT-PCR.
  • Contraindications to perform RMC: (i) gadolinium allergy, (ii) presence of metallic material in the body, such as plates, screws, incompatible pacemakers, etc. (iii) claustrophobia, (iv) severe kidney failure, (v) severe liver failure, (vi) sickle cell anemia

Treatment and study plan

Passed infection of SARS-CoV-2

Other

This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.

Primary outcomes

  1. Myocarditis

    Time frame: up to 3 months

    Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance

  2. Pericarditis

    Time frame: up to 3 months

    Prevalence of pericarditis assessed by clinical criteria

Secondary outcomes

  1. Atrial fibrillation

    Time frame: up to 3 months

    Prevalence of atrial fibrillation on EKG

  2. Ischemic heart disease

    Time frame: up to 3 months

    Prevalence of ischemic heart disease assessed by cardiac magnetic resonance

  3. Dilatation of right heart chambers

    Time frame: up to 3 months

    Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance

  4. Valvular hear disease

    Time frame: up to 3 months

    Prevalence of valvular heart disease assessed by cardiac magnetic resonance

  5. Rhythm disorders

    Time frame: up to 3 months

    Prevalence of prolonged QT interval on EKG

Sponsors and collaborators

Lead sponsor

AORTICA Group

Other

Collaborators

  • Instituto de Investigación Biomédica de Salamanca
  • Salamanca University Hospital

Registry information

Official study title

Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study

Acronym: CCC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.