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Sensitivity to Acute Cerebral Ischemia in Migrainers (SAMCO-MIG)

This study is not yet open for participant recruitment.
Verified October 2017 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT03301441
First Posted: October 4, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
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.

Condition Intervention
Ischemic Stroke Migraine Migraine With Aura Other: questionnaire ef-ID Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP) [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures:
  • Proportion of patients with no-mismatch pattern on initial imaging [ Time Frame: 24 hours ]
    ratio DWI/PWI or rCBF/CTP > 0.83

  • Proportion of patients treated by recanalisation [ Time Frame: 24 hours ]
    thrombolysis and/or thrombectomy

  • Volume of brain infarction [ Time Frame: 24 hours ]
    Volume of brain infarction 24 hours after thrombolysis and/or thrombectomy

  • TICI score [ Time Frame: 24 hours ]
    Quality of revascularization after thrombolysis and/or thrombectomy

  • Modified Rankin Score [ Time Frame: 3 months ]
    Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset

  • Modified Rankin Score in patients treated by thrombolysis and/or thrombectomy [ Time Frame: 3 months ]
    Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset


Estimated Enrollment: 600
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Migrainers
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)
Other: questionnaire ef-ID Migraine

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.

Non migrainers
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
Other: questionnaire ef-ID Migraine

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.


Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients experiencing an anterior circulation brain infarction complicating the occlusion of the internal carotid artery or the first or second segment of the middle cerebral artery and admitted within 12 hours of onset
Criteria

Inclusion Criteria:

  • Males and females, 18 to 75 years old
  • Admitted to a stroke unit for an acute ischemic stroke (<12 h)
  • Angiography showing M1/M2 or intracranial internal carotid artery occlusion
  • MRI or CT acquired <24h from IS onset, using a harmonized protocol enabling calculation of the mismatch

Exclusion Criteria:

  • Individual enrolled into another study protocol with a period of exclusion still running at potential inclusion
  • Coma, dementia, linguistic problem or aphasia preventing responding to the migraine questionnaire
  • Refusal of participation
  • Persons under legal protection, guardianship or curatorship
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301441


Contacts
Contact: Anne DUCROS, MD, PhD 04 67 33 09 64 a-ducros@chu-montpellier.fr

Locations
France
CHU de Montpellier - Neurology Departement
Montpellier, France
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Anne DUCROS, MD, PhD University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03301441     History of Changes
Other Study ID Numbers: 9789
First Submitted: September 29, 2017
First Posted: October 4, 2017
Last Update Posted: October 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
migraine
migraine with aura
migraine without aura
ischemic stroke
Mismatch

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases