Ischemic StrokeSAMCO-MIGNCT03301441
Sensitivity to Acute Cerebral Ischemia in Migrainers
An observational study of Ischemic Stroke and Migraine, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Migraine, Migraine With Aura
- What is being tested?
- questionnaire ef-ID Migraine
- How many people
- 605 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2018to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- questionnaire ef-ID Migraine
- Keywords
- migraine, migraine with aura, migraine without aura, ischemic stroke, Mismatch
- Medical subject headings
- Ischemic Stroke, Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire ef-ID MigraineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: questionnaire ef-ID Migraine | |
| 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 Receives: Other: questionnaire ef-ID Migraine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (6)
Proportion of patients with no-mismatch pattern on initial imaging
ratio DWI/PWI or rCBF/CTP > 0.83
Measured: 24 hours
Proportion of patients treated by recanalisation
thrombolysis and/or thrombectomy
Measured: 24 hours
Volume of brain infarction
Volume of brain infarction 24 hours after thrombolysis and/or thrombectomy
Measured: 24 hours
TICI score
Quality of revascularization after thrombolysis and/or thrombectomy
Measured: 24 hours
Modified Rankin Score
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start9 Feb 2018
- Primary completion6 Mar 2023
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne DUCROS, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301441
- Sponsor's protocol ID
- 9789
- Acronym
- SAMCO-MIG
- Status last verified
- May 2024
- First submitted
- 29 Sep 2017
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG
- ClinicalTrials.gov ID
- NCT03301441
- Acronym / sponsor ID
- SAMCO-MIG / 9789
- Conditions
- Ischemic Stroke, Migraine, Migraine With Aura
- Keywords
- migraine, migraine with aura, migraine without aura, ischemic stroke, Mismatch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 605 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migrainers | – | Other: questionnaire ef-ID MigrainePatients 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) |
| Non migrainers | – | Other: questionnaire ef-ID MigrainePatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire ef-ID MigraineAll 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. | Other | Migrainers, Non migrainers |
Primary outcome
Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP)
Time frame: 24 hours
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.
6 secondary outcomes
Proportion of patients with no-mismatch pattern on initial imaging
Time frame: 24 hours
Proportion of patients treated by recanalisation
Time frame: 24 hours
Volume of brain infarction
Time frame: 24 hours
TICI score
Time frame: 24 hours
Modified Rankin Score
Time frame: 3 months
Modified Rankin Score in patients treated by thrombolysis and/or thrombectomy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne DUCROS, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Migraine, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mismatch ratio (MRI DWI/PWI or CT rCBF/CTP) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.