<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/NCT04421326</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0236</org_study_id>
    <nct_id>NCT04421326</nct_id>
  </id_info>
  <brief_title>Multimodal Investigation of Intracranial Clot Environment</brief_title>
  <acronym>MISO</acronym>
  <official_title>Multimodal Investigation of Intracranial Clot Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genomic Institute of Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analysis of peri clot blood collected at the acute phase of stroke in order to understand&#xD;
      physiopathological mechanisms involved in the cerebrovascular damage&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been shown that immune cells accumulate around the clot at the acute phase of stroke.&#xD;
      Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular&#xD;
      integrity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Metalloproteinase 9 quantification</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Metalloproteinase 2 quantification</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytokines levels</measure>
    <time_frame>60 months</time_frame>
    <description>Proteomic analysis of cytokines IL-1β, TNF-α, IL-6</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Acute Ichemic Stroke</condition>
  <condition>Brain Ischemia</condition>
  <arm_group>
    <arm_group_label>Patients with acute ischemic stroke</arm_group_label>
    <description>Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analysis of the clot</intervention_name>
    <description>Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy</description>
    <arm_group_label>Patients with acute ischemic stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic&#xD;
        stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Over 18 years of age,&#xD;
&#xD;
          2. Non-dependent for activities of daily living prior to the onset of the MI (Modified&#xD;
             Rankin Score &gt;2)&#xD;
&#xD;
          3. Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or&#xD;
             angio-scanner).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients initially admitted but for whom endovascular treatment will not finally be&#xD;
             performed (re-infusion, catheterization failure...) will be excluded from the study.&#xD;
&#xD;
          2. Major patients under guardianship or curatorship or patients deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent COSTALAT, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montpellier University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cyril DARGAZANLI, MD MSc</last_name>
    <phone>467337532</phone>
    <phone_ext>+33</phone_ext>
    <email>c-dargazanli@chu-montpellier.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vincent COSTALAT, MD PhD</last_name>
    <phone>467337532</phone>
    <phone_ext>+33</phone_ext>
    <email>v-costalat@chu-montpellier.fr</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Blood Brain Barrier</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Thrombus</keyword>
  <keyword>Interventional Neuroradiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04421326
org study id: RECHMPL18_0236
nct id: NCT04421326
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Analysis of peri clot blood collected at the acute phase of stroke in order to understand
      physiopathological mechanisms involved in the cerebrovascular damage
It has been shown that immune cells accumulate around the clot at the acute phase of stroke.
      Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular
      integrity.
observational model: Cohort
time perspective: Prospective
measure: Metalloproteinase 9 quantification
time frame: 60 months
measure: Metalloproteinase 2 quantification
time frame: 60 months
measure: Cytokines levels
time frame: 60 months
description: Proteomic analysis of cytokines IL-1β, TNF-α, IL-6
arm group label: Patients with acute ischemic stroke
description: Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke
intervention type: Other
intervention name: Analysis of the clot
description: Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy
arm group label: Patients with acute ischemic stroke
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Vincent COSTALAT, MD PhD
role: Principal Investigator
affiliation: Montpellier University Hospital
last name: Cyril DARGAZANLI, MD MSc
phone: 467337532
phone ext: +33
email: c-dargazanli@chu-montpellier.fr
last name: Vincent COSTALAT, MD PhD
phone: 467337532
phone ext: +33
email: v-costalat@chu-montpellier.fr
responsible party type: Sponsor
mesh term: Brain Ischemia
mesh term: Ischemia
sharing ipd: No