- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04413071
Cardiac COVID-19 Health Care Workers (CCC)
Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Salamanca, Spania, 37007
- University Hospital of Salamanca
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Health care workers
Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.
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This is an observational design.
Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Myocarditis
Tidsramme: up to 3 months
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Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
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up to 3 months
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Pericarditis
Tidsramme: up to 3 months
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Prevalence of pericarditis assessed by clinical criteria
|
up to 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Atrial fibrillation
Tidsramme: up to 3 months
|
Prevalence of atrial fibrillation on EKG
|
up to 3 months
|
Ischemic heart disease
Tidsramme: up to 3 months
|
Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
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up to 3 months
|
Dilatation of right heart chambers
Tidsramme: up to 3 months
|
Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
|
up to 3 months
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Valvular hear disease
Tidsramme: up to 3 months
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Prevalence of valvular heart disease assessed by cardiac magnetic resonance
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up to 3 months
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Rhythm disorders
Tidsramme: up to 3 months
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Prevalence of prolonged QT interval on EKG
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up to 3 months
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Medfødte abnormiteter
- Kardiomyopatier
- Kardiovaskulære abnormiteter
- Covid-19
- Coronavirus-infeksjoner
- Myokarditt
- Hjertefeil, medfødt
Andre studie-ID-numre
- CCC_2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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