EPIdemiological Approaches to the Cardiovascular Conseque... | NCT04498091

Studies
EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

NCT04498091

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Unknown status

Last Update Posted

Aug 4, 2020Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2020Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 2021Estimated

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

Aug 3, 2020

Last Update Posted Date

Aug 4, 2020Actual

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

The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with SARS-CoV2. Investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the investigators investigated whether COVID-19-related sepsis and/or respiratory failure could be an underlying mechanism of MI2.

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
A	Type 2 MI with COVID-19	Biological: Biological data Other: Clinical data
B	Type 2 without COVID-19	Biological: Biological data Other: Clinical data
C	Type 2 MI with pneumonia without COVID-19	Biological: Biological data Other: Clinical data
D	Type 2 MI without pneumonia and without COVID-19	Biological: Biological data Other: Clinical data

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterizing type 2 myocardial infarction associated with CoV-2 SARS infection		Through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without pneumonia
patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without COVID 19

Exclusion Criteria:

None

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 with acute type 2 MI

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