An observational study in Ischemic Stroke, Migraine and Migraine With Aura, sponsored by University Hospital, Montpellier. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University Hospital, Montpellier · Observational
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.
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
Exclusion Criteria:
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
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.
Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP)
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.
Time frame: 24 hours
Proportion of patients with no-mismatch pattern on initial imaging
ratio DWI/PWI or rCBF/CTP \> 0.83
Time frame: 24 hours
Proportion of patients treated by recanalisation
thrombolysis and/or thrombectomy
Time frame: 24 hours
Volume of brain infarction
Volume of brain infarction 24 hours after thrombolysis and/or thrombectomy
Time frame: 24 hours
TICI score
Quality of revascularization after thrombolysis and/or thrombectomy
Time frame: 24 hours
Modified Rankin Score
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
Time frame: 3 months
Modified Rankin Score in patients treated by thrombolysis and/or thrombectomy
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
Time frame: 3 months
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier