NCT04823182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2022

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

March 26, 2021

Last Update Submit

September 23, 2021

Conditions

SARS-CoV InfectionCovid19Cardiomyopathies

Keywords

Cardiac Magnetic Resonance ImagingCOVID19Cardiomyopathy

Outcome Measures

Primary Outcomes (6)

  • Left ventricular (LV) ejection fraction

    Cardiac Magnetic Resonance finding

    Day 0

  • LV end diastolic volume

    Cardiac Magnetic Resonance finding

    Day 0

  • Right ventricular ejection fraction

    Cardiac Magnetic Resonance finding

    Day 0

  • Native T1, T2

    Cardiac Magnetic Resonance finding

    Day 0

  • Late gadolinium enhancement

    Cardiac Magnetic Resonance finding

    Day 0

  • Pericardial abnormalities

    Cardiac Magnetic Resonance finding

    Day 0

Secondary Outcomes (2)

  • Immunity parameters

    Day 0

  • Markers of coagulation and endothelial cell activation

    Day 0

Study Arms (1)

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

Interventions

Cardiovascular Magnetic Resonance ImagingDIAGNOSTIC_TEST

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
Cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Research Institute Dublin

Dublin, D07 KWR1, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 39261512DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19Cardiomyopathies

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Robert A Byrne, MB BCh PhD

    CVRI Dublin at Mater Private Hospital

    PRINCIPAL INVESTIGATOR

  • Roisin Colleran, MB BCh

    CVRI Dublin at Mater Private Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

February 16, 2021

Primary Completion

September 22, 2021

Study Completion

September 22, 2022

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations

IE(1)