Stroke Observatory of Caen-Normandie Metropole (NORMANDYSTROKE)
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| ClinicalTrials.gov Identifier: NCT03684226 |
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Recruitment Status : Unknown
Verified June 2018 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : September 25, 2018
Last Update Posted : March 5, 2019
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Sponsor:
University Hospital, Caen
Information provided by (Responsible Party):
University Hospital, Caen
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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.
| Condition or disease |
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| Stroke |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 2400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Stroke Observatory of Caen-Normandie Metropole |
| Actual Study Start Date : | May 17, 2017 |
| Estimated Primary Completion Date : | May 17, 2020 |
| Estimated Study Completion Date : | May 17, 2020 |
Primary Outcome Measures :
- Stroke incidence in Caen-Normandy Metropole [ Time Frame: 15 may 2017 to 15 may 2020 ]To determinate the incidence of stroke in Caen-Normandy Metropole
- Stroke acute mortality in Caen-Normandy Metropole [ Time Frame: 15 may 2017 to 15 may 2020 ]To determinate the incidence of Stroke acute mortality
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | 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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684226
Contacts
| Contact: Audrey BARBEDETTE, phD | 023-106-3183 ext +33 | audrey.barbedette@unicaen.fr | |
| Contact: Sophie BUTT, CRA | 023-106-3183 ext +33 | sophie.butt@unicaen.fr |
Locations
| France | |
| CHU of CAEN | Recruiting |
| Caen, France, 14000 | |
| Contact: Audrey BARBEDETTE, RI, PhD 023-106-3183 ext +33 audrey.barbedette@unicaen.fr | |
| Contact: Sophie BUTT, CRA 023-106-3183 ext +33 sophie.butt@unicaen.fr | |
| Principal Investigator: Emmanuel TOUZE, PUPH, PhD | |
Sponsors and Collaborators
University Hospital, Caen
Investigators
| Principal Investigator: | Emmanuel TOUZE, MD | CHU of CAEN |
| Responsible Party: | University Hospital, Caen |
| ClinicalTrials.gov Identifier: | NCT03684226 |
| Other Study ID Numbers: |
17-007 |
| First Posted: | September 25, 2018 Key Record Dates |
| Last Update Posted: | March 5, 2019 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |