An observational study in SARS-CoV Infection, Covid19 and Cardiomyopathies, sponsored by Cardiovascular Research Institute Dublin. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by Cardiovascular Research Institute Dublin · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 100 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Cardiovascular Research Institute Dublin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
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
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.
Also known as: Cardiac MRI
Left ventricular (LV) ejection fraction
Cardiac Magnetic Resonance finding
Time frame: Day 0
LV end diastolic volume
Cardiac Magnetic Resonance finding
Time frame: Day 0
Right ventricular ejection fraction
Cardiac Magnetic Resonance finding
Time frame: Day 0
Native T1, T2
Cardiac Magnetic Resonance finding
Time frame: Day 0
Late gadolinium enhancement
Cardiac Magnetic Resonance finding
Time frame: Day 0
Pericardial abnormalities
Cardiac Magnetic Resonance finding
Time frame: Day 0
Immunity parameters
Anti-SARS-CoV-2 total antibody testing
Time frame: 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
Time frame: Day 0
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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