University Hospital of Salamanca
Salamanca, 37007, Spain
NCT Number: NCT04413071
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.
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Notify Me18 year–71 year
All sexes
Observational
Salamanca, 37007, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
Time frame: up to 3 months
Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
Time frame: up to 3 months
Prevalence of pericarditis assessed by clinical criteria
Time frame: up to 3 months
Prevalence of atrial fibrillation on EKG
Time frame: up to 3 months
Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
Time frame: up to 3 months
Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
Time frame: up to 3 months
Prevalence of valvular heart disease assessed by cardiac magnetic resonance
Time frame: up to 3 months
Prevalence of prolonged QT interval on EKG
AORTICA Group
Other
Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
Acronym: CCC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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