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

• Conditions: Covid19; SARS-CoV Infection; Cardiomyopathies
• Interventions: Diagnostic Test: Cardiovascular Magnetic Resonance Imaging

• Registration Number: NCT04823182
• Lead Sponsor: Cardiovascular Research Institute Dublin

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.

Study Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Status Verified: 2021-09
• Primary Completion: 2021-09-22
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24
• Study Completion: 2022-09-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Cardiovascular Magnetic Resonance Imaging	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cardiovascular Research Institute Dublin; 🇮🇪 Dublin, Ireland