Clinical trial NCT03684226: Stroke Observatory of Caen-Normandie Metropole
Official title: Stroke Observatory of Caen-Normandie Metropole
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 2400
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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:

* None, unless patient opposition

Primary outcomes:
measure: Stroke incidence in Caen-Normandy Metropole
timeFrame: 15 may 2017 to 15 may 2020
measure: Stroke acute mortality in Caen-Normandy Metropole
timeFrame: 15 may 2017 to 15 may 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU of CAEN
Study officials:
affiliation: CHU of CAEN
name: Emmanuel TOUZE, MD
role: PRINCIPAL_INVESTIGATOR
References: