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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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SARS-CoV Infection, Covid19, Cardiomyopathies

Intervention / Treatment
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* Diagnostic Test: Cardiovascular Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>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 | Diagnostic Test: Cardiovascular Magnetic Resonance Imaging<br>* 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.<br>* Other names: Cardiac MRI;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Cardiac Magnetic Resonance Imaging, Cardiomyopathy