NCT03684226

Brief Summary

Stroke Observatory of Caen-Normandy Metropole provides epidemiological data in prospective collection. The primary objective is to determinate incidence of Stroke in this area. Several data sources will be crossed to allow an exhaustive identification of the cases. No intervention will be carried. The data collected will correspond to those obtained in current practice. The number of participants is estimated at 800 per year. This Observatory aims to become a qualified population register after three years, according to requirement of the french registry evaluation committee.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 17, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2020

Completed
Last Updated

March 5, 2019

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

June 7, 2018

Last Update Submit

March 2, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stroke incidence in Caen-Normandy Metropole

    To determinate the incidence of stroke in Caen-Normandy Metropole

    15 may 2017 to 15 may 2020

  • Stroke acute mortality in Caen-Normandy Metropole

    To determinate the incidence of Stroke acute mortality

    15 may 2017 to 15 may 2020

Eligibility Criteria

Age30 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caen-Normandie Metropole is a territory that includes one hundred forty five municipalities with urban, peri-urban and rural area. Total population is approaching 800 000 inhabitants

You may qualify if:

  • Any types of strokes (initial, recidivism)
  • Place of residence in Caen-Normandie Metropole

You may not qualify if:

  • None, unless patient opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of CAEN

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Emmanuel TOUZE, MD

    CHU of CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey BARBEDETTE, phD

CONTACT

Sophie BUTT, CRA

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 7, 2018

First Posted

September 25, 2018

Study Start

May 17, 2017

Primary Completion

May 17, 2020

Study Completion

May 17, 2020

Last Updated

March 5, 2019

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations