NCT04542083

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
911

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

September 4, 2020

Last Update Submit

August 11, 2023

Conditions

COVID-19Acute Cardiovascular ConditionAcute Neurovascular ConditionStrokeAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Specific mortality rate.

    1 day

Study Arms (2)

COVID-19 period

Admissions from January to December 2020

Control period

Admissions from January 2018 to December 2019

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19Stroke

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Grégoire Mercier, PU PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 9, 2020

Study Start

September 20, 2021

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations

FR(1)