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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823182
Recruitment Status : Active, not recruiting
First Posted : March 30, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Research Institute Dublin

Study Description
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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.

Condition or disease Intervention/treatment
SARS-CoV Infection Covid19 Cardiomyopathies Diagnostic Test: Cardiovascular Magnetic Resonance Imaging

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland
Actual Study Start Date : February 16, 2021
Actual Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 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.
Other Name: Cardiac MRI


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular (LV) ejection fraction [ Time Frame: Day 0 ]
    Cardiac Magnetic Resonance finding

  2. LV end diastolic volume [ Time Frame: Day 0 ]
    Cardiac Magnetic Resonance finding

  3. Right ventricular ejection fraction [ Time Frame: Day 0 ]
    Cardiac Magnetic Resonance finding

  4. Native T1, T2 [ Time Frame: Day 0 ]
    Cardiac Magnetic Resonance finding

  5. Late gadolinium enhancement [ Time Frame: Day 0 ]
    Cardiac Magnetic Resonance finding

  6. Pericardial abnormalities [ Time Frame: Day 0 ]
    Cardiac Magnetic Resonance finding


Secondary Outcome Measures :
  1. Immunity parameters [ Time Frame: Day 0 ]
    Anti-SARS-CoV-2 total antibody testing

  2. Markers of coagulation and endothelial cell activation [ Time Frame: Day 0 ]
    Including fibrinogen, D-dimer, von Willebrand factor antigen, von Willebrand factor propeptide, soluble thrombomodulin, activated protein C, and cytokine arrays


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823182


Locations
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Ireland
Cardiovascular Research Institute Dublin
Dublin, Ireland, D07 KWR1
Sponsors and Collaborators
Cardiovascular Research Institute Dublin
Investigators
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Principal Investigator: Robert A Byrne, MB BCh PhD CVRI Dublin at Mater Private Hospital
Principal Investigator: Roisin Colleran, MB BCh CVRI Dublin at Mater Private Hospital
More Information
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Responsible Party: Cardiovascular Research Institute Dublin
ClinicalTrials.gov Identifier: NCT04823182    
Other Study ID Numbers: SETANTA_Study_Protocol_V2.0
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardiovascular Research Institute Dublin:
Cardiac Magnetic Resonance Imaging
COVID19
Cardiomyopathy
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Heart Diseases
Cardiomyopathies
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Diseases