NCT04498065

Brief Summary

Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

August 3, 2020

Last Update Submit

September 20, 2022

Conditions

Covid19Non Ischemic Myocardial InjuryMyocardial InfarctionMyocarditisTroponin Elevation

Outcome Measures

Primary Outcomes (1)

  • characterize the myocardial damage associated with CoV-2 SARS infection

    Myocardtitis diagnosis in patients COVID+ and troponin+

    Through study completion, an average of 2 years

Study Arms (2)

A

COVID positive and Troponin positive

Biological: Biological dataOther: Clinical data

B

COVID positive and Troponin negative

Biological: Biological dataOther: Clinical data

Interventions

Biological dataBIOLOGICAL

Biological data

AB
Clinical dataOTHER

Clinical data

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to CHU Dijon Bourgogne for COVID-19

You may qualify if:

  • COVID-19 positive patient hospitalized \< 72 h after symptoms onset with troponin assessement.

You may not qualify if:

  • patients hospitalized \> 72h after symptom onset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

COVID-19Myocardial InfarctionMyocarditis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiomyopathies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 4, 2020

Study Start

March 1, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

FR(1)