NCT03379857

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

7 years

First QC Date

September 29, 2017

Last Update Submit

February 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluation Cannabis use

    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

    12 months.

Study Arms (1)

Cannabis User

OTHER
Other: Drug urinal test

Interventions

Non Applicable

Also known as: Magnetic Resonance Imaging, Computerized Tomography Scan, Transcranial Doppler Ultrasound
Cannabis User

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subject with psychiatric disorder, unable to understand the study or cooperate
  • Subject under guardianship or forfeiture of liberty
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chu Jean Minjoz

Besançon, 25030, France

Location

Unite Neuro-Vasculaire

Colmar, 68024, France

Location

Chu Bocage

Dijon, 21079, France

Location

C.H. G. Muller

Mulhouse, 68070, France

Location

Hopital Central

Nancy, 54035, France

Location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Magnetic Resonance SpectroscopyUltrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesEchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, Neurological

Study Officials

  • Valérie WOLFF, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Cannabis User
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2017

First Posted

December 20, 2017

Study Start

January 11, 2018

Primary Completion

January 11, 2025

Study Completion

January 11, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations