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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular Magnetic Resonance Imaging | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Robert A Byrne, MB BCh PhD | CVRI Dublin at Mater Private Hospital | Principal Investigator |
| Roisin Colleran, MB BCh | CVRI Dublin at Mater Private Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Institute Dublin | Dublin | D07 KWR1 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39261512 | Derived | 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, Szeplaki G, Heffernan E, Hannan M, O'Donnell JS, Byrne RA. Symptom burden, coagulopathy and heart disease after acute SARS-CoV-2 infection in primary practice. Sci Rep. 2024 Sep 11;14(1):21229. doi: 10.1038/s41598-024-71535-8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 21, 2024 | |
| Reset | Jan 15, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 21, 2024 | Jan 15, 2025 |
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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|
| Day 0 |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |