- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04413071
Cardiac COVID-19 Health Care Workers (CCC)
Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Salamanca, Spanien, 37007
- University Hospital of Salamanca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Tvärsnitt
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Health care workers
Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.
|
This is an observational design.
Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Myocarditis
Tidsram: up to 3 months
|
Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
|
up to 3 months
|
|
Pericarditis
Tidsram: up to 3 months
|
Prevalence of pericarditis assessed by clinical criteria
|
up to 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Atrial fibrillation
Tidsram: up to 3 months
|
Prevalence of atrial fibrillation on EKG
|
up to 3 months
|
|
Ischemic heart disease
Tidsram: up to 3 months
|
Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
|
up to 3 months
|
|
Dilatation of right heart chambers
Tidsram: up to 3 months
|
Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
|
up to 3 months
|
|
Valvular hear disease
Tidsram: up to 3 months
|
Prevalence of valvular heart disease assessed by cardiac magnetic resonance
|
up to 3 months
|
|
Rhythm disorders
Tidsram: up to 3 months
|
Prevalence of prolonged QT interval on EKG
|
up to 3 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Medfödda abnormiteter
- Kardiomyopatier
- Kardiovaskulära avvikelser
- Covid-19
- Coronavirusinfektioner
- Myokardit
- Hjärtfel, medfödda
Andra studie-ID-nummer
- CCC_2020
Plan för individuella deltagardata (IPD)
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