Cardiac COVID-19 Health Care Workers

Completed

• Conditions: Cardiac Magnetic Resonance; Myocarditis; SARS-CoV 2; Coronavirus; COVID-19; Cardiac Anomaly
• Interventions: Other: Passed infection of SARS-CoV-2

• Registration Number: NCT04413071
• Lead Sponsor: AORTICA Group

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

Study Timeline

• Study First Submitted: 2020-05-23
• Study Start: 2020-05-25
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Last Update Submitted: 2020-06-13
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Myocarditis	up to 3 months	Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
Pericarditis	up to 3 months	Prevalence of pericarditis assessed by clinical criteria

Secondary Outcome Measures

Name	Time	Method
Rhythm disorders	up to 3 months	Prevalence of prolonged QT interval on EKG
Atrial fibrillation	up to 3 months	Prevalence of atrial fibrillation on EKG
Dilatation of right heart chambers	up to 3 months	Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
Ischemic heart disease	up to 3 months	Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
Valvular hear disease	up to 3 months	Prevalence of valvular heart disease assessed by cardiac magnetic resonance

Trial Locations

Locations (1)

University Hospital of Salamanca; 🇪🇸 Salamanca, Spain