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Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke (CANNASTROKE)

Primary Purpose

Stroke, Cannabis Use

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Drug urinal test
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Jean MinjozRecruiting
  • Unite Neuro-VasculaireRecruiting
  • Chu BocageRecruiting
  • C.H. G. MullerRecruiting
  • Hopital CentralRecruiting
  • Les Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cannabis User

Arm Description

Outcomes

Primary Outcome Measures

Evaluation Cannabis use
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

Secondary Outcome Measures

Full Information

First Posted
September 29, 2017
Last Updated
June 11, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03379857
Brief Title
Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke
Acronym
CANNASTROKE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
January 11, 2025 (Anticipated)
Study Completion Date
January 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cannabis Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cannabis User
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabis User
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Drug urinal test
Other Intervention Name(s)
Magnetic Resonance Imaging, Computerized Tomography Scan, Transcranial Doppler Ultrasound
Intervention Description
Non Applicable
Primary Outcome Measure Information:
Title
Evaluation Cannabis use
Time Frame
12 months
Title
Reversible vasoconstriction on medical imaging of intracranial arteries at different moment
Description
medical imaging of intracranial arteries will show new stenoses (topography, number, evolution), and new ischemic or cerebral haemorrhagic lesions
Time Frame
12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie WOLFF, MD
Phone
+33 3 88 12 86 06
Email
valerie.wolff@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie WOLFF, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry MOULIN
Phone
+33 3 81 66 84 38
Email
thierry.moulin@univ-fcomte.fr
First Name & Middle Initial & Last Name & Degree
Thierry MOULIN
Facility Name
Unite Neuro-Vasculaire
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis VUILLEMET
Phone
+33 3 89 12 41 50
Email
francis.vuillemet@ch-colmar.fr
First Name & Middle Initial & Last Name & Degree
Francis VUILLEMET
Facility Name
Chu Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick BEJOT
Phone
+33 3 80 29 37 53
Email
yannick.bejot@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Yannick BEJOT
Facility Name
C.H. G. Muller
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SCHLUCK
Phone
+33 3 89 64 61 81
Email
schlucke@ch-mulhouse.fr
First Name & Middle Initial & Last Name & Degree
Eric SCHLUCK
Facility Name
Hopital Central
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien RICHARD
Phone
+33 3 83 85 22 56
Email
s.richard@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Sébastien RICHARD
Facility Name
Les Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie WOLFF, MD
Phone
33 3 88 12 86 06
Email
valerie.wolff@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Valérie WOLFF, M
First Name & Middle Initial & Last Name & Degree
Valérie LAUER
First Name & Middle Initial & Last Name & Degree
Simona SABAU PHILIPPI
First Name & Middle Initial & Last Name & Degree
Mihaela DIACONU
First Name & Middle Initial & Last Name & Degree
Danièla BINDILA
First Name & Middle Initial & Last Name & Degree
Lelyzaveta ZINCHENKO
First Name & Middle Initial & Last Name & Degree
Véronique QUENARDELLE
First Name & Middle Initial & Last Name & Degree
Stéphane KREMER

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke

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