<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246140</url>
  </required_header>
  <id_info>
    <org_study_id>5715</org_study_id>
    <nct_id>NCT02246140</nct_id>
  </id_info>
  <brief_title>Intracranial Arterial Stenosis and Resin of Cannabis Use</brief_title>
  <official_title>Prevalence of Intracranial Arterial Stenosis in Regular Resin of Cannabis Users Compared to Control Subjects: a Preliminary Study of Feasibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an association between intracranial arterial stenosis and ischemic stroke in young&#xD;
      adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis&#xD;
      in asymptomatic regular resin of cannabis users in comparison with control subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">August 2026</completion_date>
  <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of intracranial arterial stenosis on cerebral MRA</measure>
    <time_frame>3 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>-Silent ischemic stroke on cerebral MRI</measure>
    <time_frame>3 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>-new intracranial arterial stenosis at 3 month follow-up</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate a cerebral MRA at 3 months the presence of new intracranial stenosis among cannabis users, according to the prosecution or stopping use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>-Reversibility of intracranial arterial stenosis at 3 month follow-up</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate on cerebral MRA at 3 months reversibility stenosis present at T0 in cannabis users having stopped their consumption</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cannabis Users</condition>
  <arm_group>
    <arm_group_label>Cannabis users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cerebral MRI and MRA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cerebral MRI and MRA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cerebral MRI and MRA</intervention_name>
    <arm_group_label>Cannabis users</arm_group_label>
    <arm_group_label>healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  regular resin of cannabis users&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking vasoactive medications&#xD;
&#xD;
          -  taking other illicit drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie Wolff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valerie Wolff, MD</last_name>
    <phone>03 88 12 86 06</phone>
    <phone_ext>0033</phone_ext>
    <email>valerie.wolff@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg,</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerie Wolff, MD</last_name>
      <phone>03 88 12 86 06</phone>
      <phone_ext>0033</phone_ext>
      <email>valerie.wolff@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Valerie Wolff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246140
org study id: 5715
nct id: NCT02246140
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Presence of intracranial arterial stenosis on cerebral MRA
time frame: 3 months
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.
measure: -Silent ischemic stroke on cerebral MRI
time frame: 3 months
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.
measure: -new intracranial arterial stenosis at 3 month follow-up
time frame: 3 months
description: Evaluate a cerebral MRA at 3 months the presence of new intracranial stenosis among cannabis users, according to the prosecution or stopping use
measure: -Reversibility of intracranial arterial stenosis at 3 month follow-up
time frame: 3 months
description: Evaluate on cerebral MRA at 3 months reversibility stenosis present at T0 in cannabis users having stopped their consumption
arm group label: Cannabis users
arm group type: Experimental
description: Cerebral MRI and MRA
arm group label: healthy volunteers
arm group type: Active Comparator
description: Cerebral MRI and MRA
intervention type: Other
intervention name: Cerebral MRI and MRA
arm group label: Cannabis users
arm group label: healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie Wolff, MD
role: Principal Investigator
affiliation: University Hospital, Strasbourg, France
last name: Valerie Wolff, MD
phone: 03 88 12 86 06
phone ext: 0033
email: valerie.wolff@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Marijuana Abuse