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Cardiac COVID-19 Health Care Workers (CCC)

13. juni 2020 opdateret af: Pedro L Sanchez, AORTICA Group

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

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.

Studieoversigt

Detaljeret 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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

142

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Salamanca, Spanien, 37007
        • University Hospital of Salamanca

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 71 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The target population are Salamanca´s healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Myocarditis
Tidsramme: up to 3 months
Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
up to 3 months
Pericarditis
Tidsramme: up to 3 months
Prevalence of pericarditis assessed by clinical criteria
up to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
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
Valvular hear disease
Tidsramme: up to 3 months
Prevalence of valvular heart disease assessed by cardiac magnetic resonance
up to 3 months
Rhythm disorders
Tidsramme: up to 3 months
Prevalence of prolonged QT interval on EKG
up to 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. maj 2020

Primær færdiggørelse (Faktiske)

12. juni 2020

Studieafslutning (Faktiske)

12. juni 2020

Datoer for studieregistrering

Først indsendt

23. maj 2020

Først indsendt, der opfyldte QC-kriterier

1. juni 2020

Først opslået (Faktiske)

2. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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