IBIS-CT: Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Study Details
Study Description
Brief Summary
The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a monocentric study. It's a case-control study with case being first-ever ischemic stroke and controls being healthy (stroke free) subject patients paired for age, sex and cardiovascular risk or hemorrhagic stroke paired for age and sex.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Ischemic stroke patients Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging |
Genetic: 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.
|
| Other: hemorragic stroke patients Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging |
Genetic: 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.
|
| Other: healthy controls Stroke-free |
Genetic: 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.
Diagnostic Test: MRI without injection
MRI at inclusion for controls
|
Outcome Measures
Primary Outcome Measures
- Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion [6 hours after inclusion]
Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)
Secondary Outcome Measures
- RNA level expression across time according growth of infarction measured at inclusion and at 3 months [inclusion and 3 months]
Each targeted genes will be measured by quantitative rt-PCR
- RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3). [at 3 months]
Each targeted genes will be measured by quantitative rt-PCR
- Targeted RNA level expression according mechanism of ischemic stroke [at 3 months]
Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR
Eligibility Criteria
Criteria
Inclusion Criteria:
-
For ischemic stroke :
-
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:
-
Not affiliated to social security
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU Brest | Brest | France |
Sponsors and Collaborators
- University Hospital, Brest
Investigators
- Principal Investigator: Serge TIMSIT, Pr, serge.timsit@chu-brest.fr
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IBIS-CT (29BRC19.0268)