StrokeCANNASTROKENCT03379857
Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke
A study testing Drug urinal test in people with Stroke and Cannabis Use, run by University Hospital, Strasbourg, France at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Stroke, Cannabis Use
- What is being tested?
- Drug urinal test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesFrance
- Study dates
- 11 Jan 2018to 11 Jan 2025
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Chu Jean Minjoz
Besançon, 25030
Unite Neuro-Vasculaire
Colmar, 68024
Chu Bocage
Dijon, 21079
C.H. G. Muller
Mulhouse, 68070
Hopital Central
Nancy, 54035
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
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.
- Conditions
- Stroke, Cannabis Use
- Being tested
- Drug urinal test
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug urinal testOther
Also called Magnetic Resonance Imaging, Computerized Tomography Scan, Transcranial Doppler Ultrasound
Non Applicable
| Study group | Role | What they receive |
|---|---|---|
| Cannabis User | Other | Not described Receives: Other: Drug urinal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Cannabis use
Measured: 12 months
Reversible vasoconstriction on medical imaging of intracranial arteries at different moment
medical imaging of intracranial arteries will show new stenoses (topography, number, evolution), and new ischemic or cerebral haemorrhagic lesions
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start11 Jan 2018
- Primary completion11 Jan 2025 (estimated)
- Study completion11 Jan 2025 (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, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cannabis User
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie WOLFF, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379857
- Sponsor's protocol ID
- 6640
- Acronym
- CANNASTROKE
- Status last verified
- Feb 2024
- First submitted
- 29 Sep 2017
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT03379857
- Acronym / sponsor ID
- CANNASTROKE / 6640
- Conditions
- Stroke, Cannabis Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 11 Jan 2025 (estimated)
- Study completion
- 11 Jan 2025 (estimated)
- First posted
- 20 Dec 2017 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cannabis User
| Arm | Type | Receives |
|---|---|---|
| Cannabis User | Other | Other: Drug urinal test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug urinal testAlso: Magnetic Resonance Imaging, Computerized Tomography Scan, Transcranial Doppler UltrasoundNon Applicable | Other | Cannabis User |
Primary outcome
Evaluation Cannabis use
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Valérie WOLFF, MD principal investigator
Hôpitaux Universitaires de Strasbourg
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug urinal test in people with Stroke and Cannabis Use, run by University Hospital, Strasbourg, France at 6 sites 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 5 inclusion and 4 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation Cannabis use (time frame: 12 months). 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 20 Feb 2024.