Clinical trial NCT04253275: Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Official title: Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
timeFrame: 6 hours after inclusion
Secondary outcomes:
measure: RNA level expression across time according growth of infarction measured at inclusion and at 3 months
timeFrame: inclusion and 3 months
measure: RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).
timeFrame: at 3 months
measure: Targeted RNA level expression according mechanism of ischemic stroke
timeFrame: at 3 months
measure: Target RNA level expression in the saliva
timeFrame: at inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: serge.timsit@chu-brest.fr
name: Serge TIMSIT, Pr
role: PRINCIPAL_INVESTIGATOR
References: