Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland

Conditions

SARS-CoV Infection, Covid19, Cardiomyopathies

Keywords

Cardiac Magnetic Resonance Imaging, COVID19, Cardiomyopathy

Brief summary

SETANTA study will investigate the incidence of cardiac abnormalities as assessed by cardiac magnetic resonance imaging in unselected patients after acute SARS-CoV-2 infection and correlation with immunological response and biomarkers of coagulation.

Detailed description

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.

Colleran R, Fitzgerald S, Rai H, McGovern L, Byrne RJ, Mansur A, Cradock A, Lavery R, Bisset J, McKeogh S, Cantwell G, O'Ciardha D, Wilson H, Begossi N, Blake N, Fitzgibbon M, McNulty J, Széplaki G, Heffernan E, Hannan M, O'Donnell JS, Byrne RA.

2024-09-112 citations

10.1038/s41598-024-71535-8

Prevalence of abnormalities on cardiac MRI in unselected patients after recovery from acute SARS-CoV-2 infection and correlation with markers of immunity and coagulation: the SETANTA study

Róisín Colleran, Roger Byrne, Andrea Cradock, Darach O’Ciardha, S McKeogh et al. (14 authors)

European Heart Journal2022-10-01

10.1093/eurheartj/ehac544.939

15 Prevalence and characteristics of abnormalities on cardiac MRI in unselected patients after recovery from acute SARS-CoV-2 infection and correlation with markers of immunity and coagulation: the Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland (SETANTA)

Róisín Colleran, RJ Byrne, Andrea Cradock, Darach O’Ciardha, S McKeogh et al. (15 authors)

2022-10-01

10.1136/heartjnl-2022-ics.15

32 Prevalence and characteristics of abnormalities on cardiac MRI in primary care following recovery from acute SARS-CoV-2 infection and correlation with markers of immunity and coagulation: primary results of the setanta study

Róisín Colleran, Rosalind Byrne, Andrea Cradock, Darach O’Ciardha, Shane Keogh et al. (14 authors)

2021-10-01

10.1136/heartjnl-2021-ics.32

Interventions

DIAGNOSTIC_TESTCardiovascular Magnetic Resonance Imaging

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Patients 18 years or older 2. Written informed consent 3. 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

1. Prior history of myocarditis or ischemic heart disease 2. General contraindications for Magnetic Resonance Imaging e.g. Magnetic Resonance unsafe pacemaker, devices, implants etc. 3. Contraindication to gadolinium (estimated glomerular filtration rate \<30 ml/min) 4. Contraindication to Regadenoson, including cardiac conduction disease, asthma, seizures, pregnancy or breast-feeding 5. Inability to provide written informed consent, to fill out the safety questionnaire, or to fully cooperate with the scan and breath holds 6. Insufficient Cardiac Magnetic Resonance image quality

Design outcomes

Primary

Measure	Time frame	Description
Pericardial abnormalities	Day 0	Cardiac Magnetic Resonance finding
Native T1, T2	Day 0	Cardiac Magnetic Resonance finding
Late gadolinium enhancement	Day 0	Cardiac Magnetic Resonance finding
Left ventricular (LV) ejection fraction	Day 0	Cardiac Magnetic Resonance finding
LV end diastolic volume	Day 0	Cardiac Magnetic Resonance finding
Right ventricular ejection fraction	Day 0	Cardiac Magnetic Resonance finding

Secondary

Measure	Time frame	Description
Markers of coagulation and endothelial cell activation	Day 0	Including fibrinogen, D-dimer, von Willebrand factor antigen, von Willebrand factor propeptide, soluble thrombomodulin, activated protein C, and cytokine arrays
Immunity parameters	Day 0	Anti-SARS-CoV-2 total antibody testing

Countries

Ireland

Outcome results

None listed