StrokeNORMANDYSTROKENCT03684226
Stroke Observatory of Caen-Normandie Metropole
An observational study of Stroke, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days and older
- Conditions the study is for
- Stroke
- How many people
- 2,400 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2017to 17 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Any types of strokes (initial, recidivism)
- Place of residence in Caen-Normandie Metropole
- Age higher than 30 days (exclusion of perinatal stroke)
Who cannot join
- None, unless patient opposition
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU of CAEN
Caen, 14000
Audrey BARBEDETTE, RI, PhD, 023-106-3183 ext. +33, audrey.barbedette@unicaen.fr
Sophie BUTT, CRA, 023-106-3183 ext. +33, sophie.butt@unicaen.fr
About this study
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.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke incidence in Caen-Normandy Metropole
To determinate the incidence of stroke in Caen-Normandy Metropole
Measured: 15 may 2017 to 15 may 2020
Stroke acute mortality in Caen-Normandy Metropole
To determinate the incidence of Stroke acute mortality
Measured: 15 may 2017 to 15 may 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start17 May 2017
- Primary completion17 May 2020 (estimated)
- Study completion17 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel TOUZE, MD, Principal investigator, CHU of CAEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684226
- Sponsor's protocol ID
- 17-007
- Acronym
- NORMANDYSTROKE
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Observatory of Caen-Normandie Metropole
- ClinicalTrials.gov ID
- NCT03684226
- Acronym / sponsor ID
- NORMANDYSTROKE / 17-007
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 17 May 2020 (estimated)
- Study completion
- 17 May 2020 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Any types of strokes (initial, recidivism)
- Place of residence in Caen-Normandie Metropole
- Age higher than 30 days (exclusion of perinatal stroke)
Key exclusion criteria (1 listed)
- None, unless patient opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel TOUZE, MD principal investigator
CHU of CAEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey BARBEDETTE, phD (023-106-3183 ext. +33, audrey.barbedette@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke incidence in Caen-Normandy Metropole (time frame: 15 may 2017 to 15 may 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.