Back to resultsIntracranial Arterial Stenosis and Resin of Cannabis Use
Primary Purpose
Cannabis Users
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cerebral MRI and MRA
Sponsored by
About this trial
This is an interventional diagnostic trial for Cannabis Users
Eligibility Criteria
Inclusion Criteria:
- regular resin of cannabis users
Exclusion Criteria:
- taking vasoactive medications
- taking other illicit drugs
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cannabis users
healthy volunteers
Arm Description
Cerebral MRI and MRA
Cerebral MRI and MRA
Outcomes
Primary Outcome Measures
Presence of intracranial arterial stenosis on cerebral MRA
Rate on cerebral MRA the presence of cerebral Intracranial Arterial Stenosis segmental narrowing defined by at least two intra-cranial arteries compared with a cohort of non cannabis controls subjects.
Secondary Outcome Measures
-Silent ischemic stroke on cerebral MRI
Evaluate on cerebral MRI the presence of sequelae of ischemic stroke defined by a parenchymal hyperintensity in a vascular territory defined on a T2 sequence.
-new intracranial arterial stenosis at 3 month follow-up
Evaluate a cerebral MRA at 3 months the presence of new intracranial stenosis among cannabis users, according to the prosecution or stopping use
-Reversibility of intracranial arterial stenosis at 3 month follow-up
Evaluate on cerebral MRA at 3 months reversibility stenosis present at T0 in cannabis users having stopped their consumption
Full Information
NCT ID
NCT02246140
First Posted
September 17, 2014
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02246140
Brief Title
Intracranial Arterial Stenosis and Resin of Cannabis Use
Official Title
Prevalence of Intracranial Arterial Stenosis in Regular Resin of Cannabis Users Compared to Control Subjects: a Preliminary Study of Feasibility
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is an association between intracranial arterial stenosis and ischemic stroke in young adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Users
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cannabis users
Arm Type
Experimental
Arm Description
Cerebral MRI and MRA
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Description
Cerebral MRI and MRA
Intervention Type
Other
Intervention Name(s)
Cerebral MRI and MRA
Primary Outcome Measure Information:
Title
Presence of intracranial arterial stenosis on cerebral MRA
Description
Rate on cerebral MRA the presence of cerebral Intracranial Arterial Stenosis segmental narrowing defined by at least two intra-cranial arteries compared with a cohort of non cannabis controls subjects.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
-Silent ischemic stroke on cerebral MRI
Description
Evaluate on cerebral MRI the presence of sequelae of ischemic stroke defined by a parenchymal hyperintensity in a vascular territory defined on a T2 sequence.
Time Frame
3 months
Title
-new intracranial arterial stenosis at 3 month follow-up
Description
Evaluate a cerebral MRA at 3 months the presence of new intracranial stenosis among cannabis users, according to the prosecution or stopping use
Time Frame
3 months
Title
-Reversibility of intracranial arterial stenosis at 3 month follow-up
Description
Evaluate on cerebral MRA at 3 months reversibility stenosis present at T0 in cannabis users having stopped their consumption
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
regular resin of cannabis users
Exclusion Criteria:
taking vasoactive medications
taking other illicit drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Wolff, MD
Phone
03 88 12 86 06
Ext
0033
Email
valerie.wolff@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Wolff, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg,
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Wolff, MD
Phone
03 88 12 86 06
Ext
0033
Email
valerie.wolff@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Valerie Wolff, MD
12. IPD Sharing Statement
Learn more about this trial
Intracranial Arterial Stenosis and Resin of Cannabis Use
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