NCT03301441

Sensitivity to Acute Cerebral Ischemia in Migrainers

Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 605 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke
• Migraine
• Migraine With Aura

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-09
• Primary completion: 2023-03-06
• Completion: 2024-07-01
• First posted: 2017-10-04
• Last updated: 2024-05-29

Locations

1 site across 1 country: France