Cardiac COVID-19 Health Care Workers

NCT ID: NCT04413071

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2020-06-12

Brief Summary

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.

Detailed Description

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

Conditions

SARS-CoV 2; COVID-19; Coronavirus; Cardiac Magnetic Resonance; Myocarditis; Cardiac Anomaly

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Health care workers

Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.

Passed infection of SARS-CoV-2

Intervention Type: OTHER

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

Interventions

Passed infection of SARS-CoV-2

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salamanca University Hospital

OTHER

Sponsor Role: collaborator

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: collaborator

AORTICA Group

OTHER

Sponsor Role: lead

Responsible Party

Pedro L Sanchez

Director of the Cardiology Department, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Salamanca

Salamanca, , Spain

Countries

Spain

Other Identifiers

CCC_2020

Identifier Type: -

Identifier Source: org_study_id