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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498065
Other study ID # COTTIN AOIc 2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 31, 2022

Study information

Verified date September 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - COVID-19 positive patient hospitalized < 72 h after symptoms onset with troponin assessement. Exclusion Criteria: - patients hospitalized > 72h after symptom onset

Study Design


Intervention

Biological:
Biological data
Biological data
Other:
Clinical data
Clinical data

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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