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

Covid19 Clinical Trial

— SETANTA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04823182
• Other study ID #: SETANTA_Study_Protocol_V2.0
• Status: Active, not recruiting
• Start date: February 16, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: September 2021
• Source: Cardiovascular Research Institute Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• COVID-19
• Covid19
• Heart Diseases
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
Ireland	Cardiovascular Research Institute Dublin	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Research Institute Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular (LV) ejection fraction	Cardiac Magnetic Resonance finding	Day 0
Primary	LV end diastolic volume	Cardiac Magnetic Resonance finding	Day 0
Primary	Right ventricular ejection fraction	Cardiac Magnetic Resonance finding	Day 0
Primary	Native T1, T2	Cardiac Magnetic Resonance finding	Day 0
Primary	Late gadolinium enhancement	Cardiac Magnetic Resonance finding	Day 0
Primary	Pericardial abnormalities	Cardiac Magnetic Resonance finding	Day 0
Secondary	Immunity parameters	Anti-SARS-CoV-2 total antibody testing	Day 0
Secondary	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	Day 0