NCT04823182

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Cardiovascular Research Institute Dublin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV Infection
• Covid19
• Cardiomyopathies

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiovascular 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.

Timeline

• Start date: 2021-02-16
• Primary completion: 2021-09-22
• Completion: 2022-09-22
• First posted: 2021-03-30
• Last updated: 2021-09-24

Locations

1 site across 1 country: Ireland