Clinical trial NCT04823182: Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland
Official title: Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
Covid19
Cardiomyopathies
Keywords: Cardiac Magnetic Resonance Imaging
COVID19
Cardiomyopathy
Lead sponsor: Cardiovascular Research Institute Dublin
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Left ventricular (LV) ejection fraction
timeFrame: Day 0
measure: LV end diastolic volume
timeFrame: Day 0
measure: Right ventricular ejection fraction
timeFrame: Day 0
measure: Native T1, T2
timeFrame: Day 0
measure: Late gadolinium enhancement
timeFrame: Day 0
measure: Pericardial abnormalities
timeFrame: Day 0
Secondary outcomes:
measure: Immunity parameters
timeFrame: Day 0
measure: Markers of coagulation and endothelial cell activation
timeFrame: Day 0
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Cardiovascular Research Institute Dublin
Study officials:
affiliation: CVRI Dublin at Mater Private Hospital
name: Robert A Byrne, MB BCh PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CVRI Dublin at Mater Private Hospital
name: Roisin Colleran, MB BCh
role: PRINCIPAL_INVESTIGATOR
References: