Cardiac Anomaly, Cardiac Magnetic Resonance, Coronavirus, COVID-19, Myocarditis, SARS-CoV 2
Conditions
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
Interventions
OTHERPassed infection of SARS-CoV-2
This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
Sponsors
Salamanca University Hospital
Instituto de Investigación Biomédica de Salamanca
AORTICA Group
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Dilatation of right heart chambers | up to 3 months | Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance |
| Atrial fibrillation | up to 3 months | Prevalence of atrial fibrillation on EKG |
| Rhythm disorders | up to 3 months | Prevalence of prolonged QT interval on EKG |
| Valvular hear disease | up to 3 months | Prevalence of valvular heart disease assessed by cardiac magnetic resonance |
| Ischemic heart disease | up to 3 months | Prevalence of ischemic heart disease assessed by cardiac magnetic resonance |
Countries
Spain
Outcome results
None listed