Clinical trial NCT03301441: Sensitivity to Acute Cerebral Ischemia in Migrainers
Official title: Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischemic Stroke
Migraine
Migraine With Aura
Keywords: migraine
migraine with aura
migraine without aura
ischemic stroke
Mismatch
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP)
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of patients with no-mismatch pattern on initial imaging
timeFrame: 24 hours
measure: Proportion of patients treated by recanalisation
timeFrame: 24 hours
measure: Volume of brain infarction
timeFrame: 24 hours
measure: TICI score
timeFrame: 24 hours
measure: Modified Rankin Score
timeFrame: 3 months
measure: Modified Rankin Score in patients treated by thrombolysis and/or thrombectomy
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Neurology Departement
Study officials:
affiliation: University Hospital, Montpellier
name: Anne DUCROS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: