<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/NCT03301441</url>
  </required_header>
  <id_info>
    <org_study_id>9789</org_study_id>
    <nct_id>NCT03301441</nct_id>
  </id_info>
  <brief_title>Sensitivity to Acute Cerebral Ischemia in Migrainers</brief_title>
  <acronym>SAMCO-MIG</acronym>
  <official_title>Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Sensitivity to Acute Middle cerebral or intracranial Carotid artery Occlusion in MIGrainers&#xD;
      (SMCO-MIG) is a prospective multi-center study to determine if migraine induces a faster&#xD;
      infarct growth as assessed by initial multimodal imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ischemic stroke results from the occlusion of a brain artery by a clot. Early&#xD;
      revascularization by thrombolysis and thrombectomy promotes neurological recovery by saving&#xD;
      the area of ischemic penumbra. Progression of ischemic stroke is evaluated on multimodal&#xD;
      imaging by the &quot;mismatch ratio&quot; between necrotized core and salvageable hypoperfused volumes.&#xD;
&#xD;
      Migraine affects 12% of the population. Although considered as a benign condition, migraine,&#xD;
      particularly with aura, is a risk factor for ischemic stroke. Based on pathophysiological&#xD;
      hypothesis and the result of one study, which had several limitations, it's suggest that&#xD;
      migraine might increase the sensitivity to cerebral ischemia and induce a faster infarct&#xD;
      growth.&#xD;
&#xD;
      The main objective of the study is to determine if the mismatch ratio between irreversibly&#xD;
      injured and hypoperfused volumes, measured on initial imaging (MRI or CT) during acute&#xD;
      ischemia due to occlusion of the middle cerebral artery or the intracranial internal carotid&#xD;
      artery, varies according to the migraine status.&#xD;
&#xD;
      A multicentric prospective cohort will be conduct, outcome study. The initial multimodal&#xD;
      imaging (MRI or CT) will be acquired routinely using a harmonized protocol in any patient&#xD;
      suspected of an acute stroke. All consecutive patients eligible to the study will be included&#xD;
      within 7 days of their initial admission, and evaluated with a short questionnaire&#xD;
      classifying them as &quot;migrainers&quot; whose status will undergo a detailed validation at 3 months&#xD;
      by a migraine expert, and &quot;non-migrainers&quot; whose status will be validated by repeating the&#xD;
      short questionnaire at the follow-up visit at 3 months. All radiological data will be&#xD;
      analyzed centrally after the end of the recruitment, by investigators blinded to the migraine&#xD;
      status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 9, 2018</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</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>Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP)</measure>
    <time_frame>24 hours</time_frame>
    <description>Raw data acquired on initial multimodal imaging done routinely, using a harmonized protocol in any patient suspected of an acute stroke before the enrollment in the study. The mismatch ratio will be calculated after recruitement completion by investigators blinded to the migraine status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with no-mismatch pattern on initial imaging</measure>
    <time_frame>24 hours</time_frame>
    <description>ratio DWI/PWI or rCBF/CTP &gt; 0.83</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients treated by recanalisation</measure>
    <time_frame>24 hours</time_frame>
    <description>thrombolysis and/or thrombectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of brain infarction</measure>
    <time_frame>24 hours</time_frame>
    <description>Volume of brain infarction 24 hours after thrombolysis and/or thrombectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TICI score</measure>
    <time_frame>24 hours</time_frame>
    <description>Quality of revascularization after thrombolysis and/or thrombectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>3 months</time_frame>
    <description>Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score in patients treated by thrombolysis and/or thrombectomy</measure>
    <time_frame>3 months</time_frame>
    <description>Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Migraine</condition>
  <condition>Migraine With Aura</condition>
  <arm_group>
    <arm_group_label>Migrainers</arm_group_label>
    <description>Patients experiencing an acute brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery. Migraine status determined by the validated French short questionnaire ef-ID Migraine (Classification into migraine without or with aura)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non migrainers</arm_group_label>
    <description>Patients experiencing an acute brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery. Migraine status determined by the validated French short questionnaire ef-ID Migraine A short questionnaire validating the absence of migraine</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire ef-ID Migraine</intervention_name>
    <description>All consecutive patients eligible to the study will be included within 7 days of their initial admission, and evaluated with a short questionnaire classifying them as &quot;migrainers&quot; whose status will undergo a detailed validation at 3 months by a migraine expert, and &quot;non-migrainers&quot; whose status will be validated by repeating the short questionnaire at the follow-up visit at 3 months.&#xD;
Initial multimodal imaging, done routinely in any stroke patient, will acquire the raw data necessary to calculate the mismatch ratio (MRI DWI/PWI or CT rCBF/CTP). All radiological data will be analyzed centrally after the end of the recruitment, by investigators blinded to the migraine status.</description>
    <arm_group_label>Migrainers</arm_group_label>
    <arm_group_label>Non migrainers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients experiencing an anterior circulation brain infarction complicating the occlusion&#xD;
        of the internal carotid artery or the first or second segment of the middle cerebral artery&#xD;
        and admitted within 12 hours of onset&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, 18 to 75 years old&#xD;
&#xD;
          -  Admitted to a stroke unit for an acute ischemic stroke (&lt;12 h)&#xD;
&#xD;
          -  Angiography showing M1/M2 or intracranial internal carotid artery occlusion&#xD;
&#xD;
          -  MRI or CT acquired &lt;24h from IS onset, using a harmonized protocol enabling&#xD;
             calculation of the mismatch&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual enrolled into another study protocol with a period of exclusion still&#xD;
             running at potential inclusion&#xD;
&#xD;
          -  Coma, dementia, linguistic problem or aphasia preventing responding to the migraine&#xD;
             questionnaire&#xD;
&#xD;
          -  Refusal of participation&#xD;
&#xD;
          -  Persons under legal protection, guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne DUCROS, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne DUCROS, MD, PhD</last_name>
    <phone>04 67 33 09 64</phone>
    <email>a-ducros@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Montpellier - Neurology Departement</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne DUCROS</last_name>
      <email>a-ducros@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>December 27, 2021</last_update_submitted>
  <last_update_submitted_qc>December 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine</keyword>
  <keyword>migraine with aura</keyword>
  <keyword>migraine without aura</keyword>
  <keyword>ischemic stroke</keyword>
  <keyword>Mismatch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Migraine with Aura</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/NCT03301441
org study id: 9789
nct id: NCT03301441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sensitivity to Acute Middle cerebral or intracranial Carotid artery Occlusion in MIGrainers
      (SMCO-MIG) is a prospective multi-center study to determine if migraine induces a faster
      infarct growth as assessed by initial multimodal imaging.
Ischemic stroke results from the occlusion of a brain artery by a clot. Early
      revascularization by thrombolysis and thrombectomy promotes neurological recovery by saving
      the area of ischemic penumbra. Progression of ischemic stroke is evaluated on multimodal
      imaging by the "mismatch ratio" between necrotized core and salvageable hypoperfused volumes.

      Migraine affects 12% of the population. Although considered as a benign condition, migraine,
      particularly with aura, is a risk factor for ischemic stroke. Based on pathophysiological
      hypothesis and the result of one study, which had several limitations, it's suggest that
      migraine might increase the sensitivity to cerebral ischemia and induce a faster infarct
      growth.

      The main objective of the study is to determine if the mismatch ratio between irreversibly
      injured and hypoperfused volumes, measured on initial imaging (MRI or CT) during acute
      ischemia due to occlusion of the middle cerebral artery or the intracranial internal carotid
      artery, varies according to the migraine status.

      A multicentric prospective cohort will be conduct, outcome study. The initial multimodal
      imaging (MRI or CT) will be acquired routinely using a harmonized protocol in any patient
      suspected of an acute stroke. All consecutive patients eligible to the study will be included
      within 7 days of their initial admission, and evaluated with a short questionnaire
      classifying them as "migrainers" whose status will undergo a detailed validation at 3 months
      by a migraine expert, and "non-migrainers" whose status will be validated by repeating the
      short questionnaire at the follow-up visit at 3 months. All radiological data will be
      analyzed centrally after the end of the recruitment, by investigators blinded to the migraine
      status.
observational model: Cohort
time perspective: Prospective
measure: Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP)
time frame: 24 hours
description: Raw data acquired on initial multimodal imaging done routinely, using a harmonized protocol in any patient suspected of an acute stroke before the enrollment in the study. The mismatch ratio will be calculated after recruitement completion by investigators blinded to the migraine status.
measure: Proportion of patients with no-mismatch pattern on initial imaging
time frame: 24 hours
description: ratio DWI/PWI or rCBF/CTP > 0.83
measure: Proportion of patients treated by recanalisation
time frame: 24 hours
description: thrombolysis and/or thrombectomy
measure: Volume of brain infarction
time frame: 24 hours
description: Volume of brain infarction 24 hours after thrombolysis and/or thrombectomy
measure: TICI score
time frame: 24 hours
description: Quality of revascularization after thrombolysis and/or thrombectomy
measure: Modified Rankin Score
time frame: 3 months
description: Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
measure: Modified Rankin Score in patients treated by thrombolysis and/or thrombectomy
time frame: 3 months
description: Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
arm group label: Migrainers
description: Patients experiencing an acute brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery. Migraine status determined by the validated French short questionnaire ef-ID Migraine (Classification into migraine without or with aura)
arm group label: Non migrainers
description: Patients experiencing an acute brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery. Migraine status determined by the validated French short questionnaire ef-ID Migraine A short questionnaire validating the absence of migraine
intervention type: Other
intervention name: questionnaire ef-ID Migraine
description: All consecutive patients eligible to the study will be included within 7 days of their initial admission, and evaluated with a short questionnaire classifying them as "migrainers" whose status will undergo a detailed validation at 3 months by a migraine expert, and "non-migrainers" whose status will be validated by repeating the short questionnaire at the follow-up visit at 3 months.
Initial multimodal imaging, done routinely in any stroke patient, will acquire the raw data necessary to calculate the mismatch ratio (MRI DWI/PWI or CT rCBF/CTP). All radiological data will be analyzed centrally after the end of the recruitment, by investigators blinded to the migraine status.
arm group label: Migrainers
arm group label: Non migrainers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Anne DUCROS, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
last name: Anne DUCROS, MD, PhD
phone: 04 67 33 09 64
email: a-ducros@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Ischemic Stroke
mesh term: Migraine with Aura