Clinical trial NCT04413071: Cardiac COVID-19 Health Care Workers
Official title: Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
COVID-19
Coronavirus
Cardiac Magnetic Resonance
Myocarditis
Cardiac Anomaly
Lead sponsor: AORTICA Group
Sponsor class: OTHER
Collaborators: name: Salamanca University Hospital
name: Instituto de Investigación Biomédica de Salamanca
First posted: 2020-06-02
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

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

Primary outcomes:
measure: Myocarditis
timeFrame: up to 3 months
measure: Pericarditis
timeFrame: up to 3 months
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: up to 3 months
measure: Ischemic heart disease
timeFrame: up to 3 months
measure: Dilatation of right heart chambers
timeFrame: up to 3 months
measure: Valvular hear disease
timeFrame: up to 3 months
measure: Rhythm disorders
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University Hospital of Salamanca
Study officials:
References: