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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Stroke; Migraine; Migraine With Aura
• Intervention / Treatment: Other: questionnaire ef-ID Migraine

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.

• Study Type: Observational
• Enrollment (Actual): 605

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • CHU de Montpellier - Neurology Departement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with no-mismatch pattern on initial imaging	ratio DWI/PWI or rCBF/CTP > 0.83	24 hours
Proportion of patients treated by recanalisation	thrombolysis and/or thrombectomy	24 hours
Volume of brain infarction	Volume of brain infarction 24 hours after thrombolysis and/or thrombectomy	24 hours
TICI score	Quality of revascularization after thrombolysis and/or thrombectomy	24 hours
Modified Rankin Score	Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset	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	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Anne DUCROS, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Actual): March 6, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ischemic stroke; migraine; migraine with aura; migraine without aura; Mismatch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Stroke; Ischemic Stroke; Migraine Disorders; Migraine with Aura
• Other Study ID Numbers: 9789

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No