Covid-19, Acute Myocardial Infarctions and Strokes in France | NCT04542083

Studies
Covid-19, Acute Myocardial Infarctions and Strokes in France

NCT04542083

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Aug 16, 2023Actual

Enrollment

911Actual

Phase

Not provided

Conditions

COVID-19
Acute Cardiovascular Condition
Acute Neurovascular Condition
Stroke
Acute Myocardial Infarction

Interventions

Not provided

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 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Maximum recruitment reached

Expanded Access Info

Start Date

Sep 20, 2021Actual

Primary Completion Date

Jul 25, 2023Actual

Completion Date

Jul 25, 2023Actual

First Submitted Date

Sep 4, 2020

First Submission Date that Met QC Criteria

Sep 7, 2020

First Posted Date

Sep 9, 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 11, 2023

Last Update Posted Date

Aug 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 has had dramatic effects on health systems and on non-COVID health care.

Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.

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

911Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 period		Admissions from January to December 2020
Control period		Admissions from January 2018 to December 2019

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily number of admissions for acute cardio- and neurivascular conditions in France.	Daily number of admissions for acute cardio- and neurivascular conditions in France.	1 day

Secondary Outcomes

Measure	Description	Time Frame
Specific mortality rate.	Specific mortality rate.	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Adults admitted in 2018, 2019 or 2020 in a French hospital for acute coronary syndrom or stroke

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

General population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grégoire Mercier, PU PH	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D020521	Stroke

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided