Sensitivity to Acute Cerebral Ischemia in Migrainers

Ischemic Stroke Clinical Trial

— SAMCO-MIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301441
• Other study ID #: 9789
• Status: Recruiting
• Start date: February 9, 2018
• Est. completion date: May 2023

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Anne DUCROS, MD, PhD
• Phone: 04 67 33 09 64
• Email: a-ducros[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Migraine
• Migraine Disorders
• Migraine With Aura

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Montpellier - Neurology Departement	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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