MYocardial DOmmages Related to COVID-19 | NCT04498065

Studies
MYocardial DOmmages Related to COVID-19

NCT04498065

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Sep 22, 2022Actual

Enrollment

273Actual

Phase

Not provided

Conditions

Covid19
Non Ischemic Myocardial Injury
Myocardial Infarction
Myocarditis
Troponin Elevation

Interventions

Biological data
Clinical data

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

Aug 3, 2020

First Submission Date that Met QC Criteria

Aug 3, 2020

First Posted Date

Aug 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2022

Last Update Posted Date

Sep 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

273Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		COVID positive and Troponin positive	Biological: Biological data Other: Clinical data
B		COVID positive and Troponin negative	Biological: Biological data Other: Clinical data

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological data	Biological	Biological data	A B
Clinical data

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients hospitalized > 72h after symptom onset

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to CHU Dijon Bourgogne for COVID-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne		Dijon		21000	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D009203	Myocardial Infarction
D009205	Myocarditis

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided