CClinicalTrials.gg
Status unknownNCT03684226NORMANDYSTROKEUpdated Mar 5, 2019

Stroke Observatory of Caen-Normandie Metropole

An observational study in Stroke, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 30 Days and older. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,400
Ages
30 Days and older
Sex
All
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Study 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.

Read the detailed description

Stroke is the second leading cause of death (the first in women in industrialized countries), the second cause of dementia and the third leading cause of disability. For a middle-aged person, the risk of developing a stroke is 1/5 in women and 1/6 in men over a lifetime. Moreover, stroke is a disease that can be considered chronic. Indeed, in France, the survival rate one month after a stroke is 80-90%. However, at least 50% of survivors retain a severe disability and almost all require long-term care. The medico-economic impact of stroke is therefore important in both the initial and chronic phases. Nevertheless, none of the French stroke registries consider the burden of post-stroke disability. In addition, there is limited data available on the impact of geographic disparities on the prognosis of stroke. Population studies are essential to accurately identify the incidence and burden of stroke, thereby supporting public health policy, guiding the allocation of resources, and evaluating the effectiveness of preventive strategies for a population. This is why we propose to create a Norman Observatory of Stroke. It will include an urban and rural population and will aim to become a population register.

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Conditions studied

  • Stroke

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Days and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Inclusion criteria

  • Any types of strokes (initial, recidivism)
  • Place of residence in Caen-Normandie Metropole
  • Age higher than 30 days (exclusion of perinatal stroke)

Exclusion criteria

Exclusion Criteria:

  • None, unless patient opposition
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,400 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Stroke incidence in Caen-Normandy Metropole

    To determinate the incidence of stroke in Caen-Normandy Metropole

    Time frame: 15 may 2017 to 15 may 2020

  2. Stroke acute mortality in Caen-Normandy Metropole

    To determinate the incidence of Stroke acute mortality

    Time frame: 15 may 2017 to 15 may 2020

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03684226
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Sep 25, 2018
Start date
May 17, 2017
Primary completion
May 17, 2020 (estimated)
Completion
May 17, 2020 (estimated)
Last update
Mar 5, 2019

Study contacts

Audrey BARBEDETTE, phD
Contact
audrey.barbedette@unicaen.fr
023-106-3183 ext. +33
Sophie BUTT, CRA
Contact
sophie.butt@unicaen.fr
023-106-3183 ext. +33
Emmanuel TOUZE, MD
principal investigator · CHU of CAEN

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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