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MYocardial DOmmages Related to COVID-19 (DOMY COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498065
Recruitment Status : Active, not recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment
Covid19 Non Ischemic Myocardial Injury Myocardial Infarction Myocarditis Troponin Elevation Biological: Biological data Other: Clinical data

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MYocardial DOmmages Related to COVID-19
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A
COVID positive and Troponin positive
Biological: Biological data
Biological data

Other: Clinical data
Clinical data

B
COVID positive and Troponin negative
Biological: Biological data
Biological data

Other: Clinical data
Clinical data




Primary Outcome Measures :
  1. characterize the myocardial damage associated with CoV-2 SARS infection [ Time Frame: Through study completion, an average of 1 year ]
    Myocardtitis diagnosis in patients COVID+ and troponin+



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to CHU Dijon Bourgogne for COVID-19
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients hospitalized > 72h after symptom onset

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498065


Locations
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France
Chu Dijon Bourgogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04498065    
Other Study ID Numbers: COTTIN AOIc 2020
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Myocarditis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cardiomyopathies