Clinical Trials Directory

Trials / Completed

CompletedNCT04413071

Cardiac COVID-19 Health Care Workers

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

Status
Completed
Phase
Study type
Observational
Enrollment
142 (actual)
Sponsor
AORTICA Group · Academic / Other
Sex
All
Age
18 Years – 71 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2020-05-25
Primary completion
2020-06-12
Completion
2020-06-12
First posted
2020-06-02
Last updated
2020-06-16

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT04413071. Inclusion in this directory is not an endorsement.