- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379857
Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke (CANNASTROKE)
Incidence of strokes has increased these last 20 years in young population. This rise could be linked to alcohol, tobacco or drug use like cannabis. Cannabis has previously been descripted as a potential factor of reversible vasoconstriction. The main objective is to show that an exhaustive assessment of a stroke facing a young person frequently lead to a diagnostic of reversible vasoconstriction due to cannabis use. Evaluation will focus on prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in young subjects.
There's a real public healthcare interest in terms of primary and secondary prevention to evaluate the role of cannabis as a risk factor of stroke in young population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Besancon, France, 25030
- Chu Jean Minjoz
-
Colmar, France, 68024
- Unite Neuro-Vasculaire
-
Dijon, France, 21079
- CHU Bocage
-
Mulhouse, France, 68070
- C.H. G. Muller
-
Nancy, France, 54035
- Hôpital Central
-
Strasbourg, France, 67098
- Les Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject between 18 and 45 years old
- Stroke confirmed by medical imaging
- Written informed consent (subject, nearby or emergency procedure)
- Subject affiliate to a local healthcare insurance office
- For female of childbearing potential, an adequate contraceptive measur
Exclusion Criteria:
- Subject with psychiatric disorder, unable to understand the study or cooperate
- Subject under guardianship or forfeiture of liberty
- Pregnant or breastfeeding woman
- Subject in period of exclusion due to another study or still in follow-up of an interventional study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cannabis User
|
Non Applicable
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation Cannabis use
Time Frame: 12 months
|
12 months
|
|
|
Reversible vasoconstriction on medical imaging of intracranial arteries at different moment
Time Frame: 12 months.
|
medical imaging of intracranial arteries will show new stenoses (topography, number, evolution), and new ischemic or cerebral haemorrhagic lesions
|
12 months.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Valérie WOLFF, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6640
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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