Cardiac COVID-19 Health Care Workers (CCC)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV 2; Myocarditis; Coronavirus; Cardiac Magnetic Resonance; Cardiac Anomaly
• Intervention / Treatment: Other: Passed infection of SARS-CoV-2

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 Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • University Hospital of Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target population are Salamanca´s healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health care workers; Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocarditis	Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance	up to 3 months
Pericarditis	Prevalence of pericarditis assessed by clinical criteria	up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AORTICA Group
• Collaborators: Salamanca University Hospital; Instituto de Investigación Biomédica de Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Congenital Abnormalities; Cardiomyopathies; Cardiovascular Abnormalities; COVID-19; Coronavirus Infections; Myocarditis; Heart Defects, Congenital
• Other Study ID Numbers: CCC_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No