Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland (SETANTA)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Approximately 100 participants from primary care will be enrolled via General Practitioner (GP) or Primary Care Centers in Dublin. A patient information sheet (PIS) will be made accessible to participants recovering from COVID-19 via their GP practice inviting the participants to contact Cardiovascular Research Institute Dublin. The participants, subject to suitability, will be invited for a site visit over two days, where upon explicit consent being granted, the Investigators will proceed with data collection. The study population includes participants who are recovering from COVID-19 in the community.
Primary Objective
To investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected participants after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.
Secondary Objectives
- To investigate the incidence of SARS-CoV-2 immunity and
- To investigate the extent of coagulopathy persistent after acute SARS-CoV-2 infection.
Follow-up data collection points will be at 1, 6- and 12-months including assessment of major adverse cardiovascular events (MACE) such as myocardial infarction (MI), revascularization, pulmonary embolism (PE), deep venous thromboembolism (DVT), incident heart failure and stroke. 'Patient reported outcome measures' via two quality of life (QOL) questionnaires will be administered at baseline and at 6 and 12 months.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Dublin, Irland, D07 KWR1
- Cardiovascular Research Institute Dublin
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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:
- Patients 18 years or older
- Written informed consent
- Recent COVID-19 infection ≥ 6 weeks and ≤ 12 months before enrolment, as evidenced by positive reverse-transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 swab
Exclusion Criteria:
- Prior history of myocarditis or ischemic heart disease
- General contraindications for Magnetic Resonance Imaging e.g. Magnetic Resonance unsafe pacemaker, devices, implants etc.
- Contraindication to gadolinium (estimated glomerular filtration rate <30 ml/min)
- Contraindication to Regadenoson, including cardiac conduction disease, asthma, seizures, pregnancy or breast-feeding
- Inability to provide written informed consent, to fill out the safety questionnaire, or to fully cooperate with the scan and breath holds
- Insufficient Cardiac Magnetic Resonance image quality
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Cases
Cases - Recent COVID-19 infection ≥ 6 weeks and ≤ 12 months before enrolment, as evidenced by positive reverse-transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 swab
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The Cardiac MRI protocol consists of static T2 weighted in all three planes and T2 weighted imaging with fat saturation in the short axis plane.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Left ventricular (LV) ejection fraction
Tidsramme: Day 0
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Cardiac Magnetic Resonance finding
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Day 0
|
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LV end diastolic volume
Tidsramme: Day 0
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Cardiac Magnetic Resonance finding
|
Day 0
|
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Right ventricular ejection fraction
Tidsramme: Day 0
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Cardiac Magnetic Resonance finding
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Day 0
|
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Native T1, T2
Tidsramme: Day 0
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Cardiac Magnetic Resonance finding
|
Day 0
|
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Late gadolinium enhancement
Tidsramme: Day 0
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Cardiac Magnetic Resonance finding
|
Day 0
|
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Pericardial abnormalities
Tidsramme: Day 0
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Cardiac Magnetic Resonance finding
|
Day 0
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Immunity parameters
Tidsramme: Day 0
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Anti-SARS-CoV-2 total antibody testing
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Day 0
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Markers of coagulation and endothelial cell activation
Tidsramme: Day 0
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Including fibrinogen, D-dimer, von Willebrand factor antigen, von Willebrand factor propeptide, soluble thrombomodulin, activated protein C, and cytokine arrays
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Day 0
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Robert A Byrne, MB BCh PhD, CVRI Dublin at Mater Private Hospital
- Hovedetterforsker: Roisin Colleran, MB BCh, CVRI Dublin at Mater Private Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
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
- Kardiovaskulære sykdommer
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Hjertesykdommer
- Alvorlig akutt luftveissyndrom
- Covid-19
- Kardiomyopatier
Andre studie-ID-numre
- SETANTA_Study_Protocol_V2.0
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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