Identification of Biomarkers in Ischemic Stroke - Clinical Trial
NCT ID: NCT04253275
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2020-11-24
2024-02-06
Brief Summary
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Detailed Description
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Patients are followed for one year. Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y. Microvesicles samples will be taken at inclusion, 7d and 3M.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Ischemic stroke patients
Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
blood samples
Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.
Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls.
hemorragic stroke patients
Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging
blood samples
Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.
Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls.
healthy controls
Stroke-free
blood samples
Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.
Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls.
MRI without injection
MRI at inclusion for controls
Interventions
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blood samples
Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.
Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls.
MRI without injection
MRI at inclusion for controls
Eligibility Criteria
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Inclusion Criteria
* Age \> 18-year-old
* Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
* Inclusion inferior to 6 hours from stroke onset
* Initial NIHSS score \> 0 at the time of clinical examination
* Patients with multimodal imaging either through MRI or CT perfusion and supra-aortic vessels and intra-cerebral vessels (Willis circle) imaging \<0
* Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present
* For hemorragic stroke :
* Age \> 18 year-old
* Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
* Inclusion inferior to 6 hours from stroke onset
* Initial NIHSS score \> 0 at the time of clinical examination
* Hemorrhagic patients are paired for age and sex with ischemic patients
* Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present
For healthy controls :
* Age \> 18 year-old
* Stroke-free standardized questionnaire
* Initial NIHSS score = 0
* Rankin score = 0
* High risk cardiovascular subjects
* Controls are paired for age, sex and cardiovascular risk measured by a score (European Heart Score) with ischemic patients
Exclusion Criteria
* Patient under legal protection or deprived of liberty by a judicial or administrative decision
* Patient whose follow-up will be impossible
* Prior stroke
GROUP FOR ISCHEMIC STROKE :
\- Patients with TIA and a negative cerebral CT or MRI
GROUP FOR HEMORRAGIC STROKE :
* Cerebral hemorrhage related to subarachnoid hemorrhage
* Post-traumatic hemorrhage
* Hemorrhagic transformation in patients with ischemic stroke
GROUP FOR HEALTHY CONTROLS :
\- Contraindication MRI
18 Years
99 Years
ALL
Yes
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Locations
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CHRU Brest
Brest, , France
Countries
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Other Identifiers
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IBIS-CT (29BRC19.0268)
Identifier Type: -
Identifier Source: org_study_id
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