SARS-CoV InfectionSETANTANCT04823182
Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland
An observational study of SARS-CoV Infection and Covid19, run by Cardiovascular Research Institute Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Covid19, Cardiomyopathies
- What is being tested?
- Cardiovascular Magnetic Resonance Imaging
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 16 Feb 2021to 22 Sep 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Cardiovascular Magnetic Resonance Imaging
- Keywords
- Cardiac Magnetic Resonance Imaging, COVID19, Cardiomyopathy
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic Resonance ImagingDiagnostic test
Also called Cardiac MRI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Cardiovascular Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular (LV) ejection fraction
Cardiac Magnetic Resonance finding
Measured: Day 0
LV end diastolic volume
Cardiac Magnetic Resonance finding
Measured: Day 0
Right ventricular ejection fraction
Cardiac Magnetic Resonance finding
Measured: Day 0
Native T1, T2
Cardiac Magnetic Resonance finding
Measured: Day 0
Late gadolinium enhancement
Cardiac Magnetic Resonance finding
Measured: Day 0
Pericardial abnormalities
Cardiac Magnetic Resonance finding
Measured: Day 0
Secondary outcomes (2)
Immunity parameters
Anti-SARS-CoV-2 total antibody testing
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start16 Feb 2021
- Primary completion22 Sep 2021
- Study completion22 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Institute Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A Byrne, MB BCh PhD, Principal investigator, CVRI Dublin at Mater Private HospitalRoisin Colleran, MB BCh, Principal investigator, CVRI Dublin at Mater Private Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823182
- Sponsor's protocol ID
- SETANTA_Study_Protocol_V2.0
- Acronym
- SETANTA
- Status last verified
- Sep 2021
- First submitted
- 26 Mar 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39261512
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland
- ClinicalTrials.gov ID
- NCT04823182
- Acronym / sponsor ID
- SETANTA / SETANTA_Study_Protocol_V2.0
- Conditions
- SARS-CoV Infection, Covid19, Cardiomyopathies
- Keywords
- Cardiac Magnetic Resonance Imaging, COVID19, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardiovascular Research Institute DublinUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2022 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Cardiovascular Magnetic Resonance ImagingCases - 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Magnetic Resonance ImagingAlso: Cardiac MRIThe Cardiac MRI protocol consists of static T2 weighted in all three planes and T2 weighted imaging with fat saturation in the short axis plane. | Diagnostic test | Cases |
Primary outcome
Left ventricular (LV) ejection fraction
Time frame: Day 0
Cardiac Magnetic Resonance finding
LV end diastolic volume
Time frame: Day 0
Cardiac Magnetic Resonance finding
Right ventricular ejection fraction
Time frame: Day 0
Cardiac Magnetic Resonance finding
Native T1, T2
Time frame: Day 0
Cardiac Magnetic Resonance finding
Late gadolinium enhancement
Time frame: Day 0
Cardiac Magnetic Resonance finding
Pericardial abnormalities
Time frame: Day 0
Cardiac Magnetic Resonance finding
2 secondary outcomes
Immunity parameters
Time frame: Day 0
Markers of coagulation and endothelial cell activation
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Derived from this study: PubMed 39261512Colleran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Byrne, MB BCh PhD principal investigator
CVRI Dublin at Mater Private Hospital
Roisin Colleran, MB BCh principal investigator
CVRI Dublin at Mater Private Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Covid19, run by Cardiovascular Research Institute Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular (LV) ejection fraction (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.