Identification of Biomarkers in Ischemic Stroke - Clinical Trial

NCT ID: NCT04253275

Last Updated: 2024-03-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2024-02-06

Brief Summary

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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

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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.

Conditions

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Stroke, Ischemic Stroke Hemorrhagic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ischemic stroke patients

Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging

Group Type OTHER

blood samples

Intervention Type GENETIC

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

Group Type OTHER

blood samples

Intervention Type GENETIC

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

Group Type OTHER

blood samples

Intervention Type GENETIC

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type GENETIC

MRI without injection

MRI at inclusion for controls

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serge TIMSIT, Pr

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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CHRU Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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IBIS-CT (29BRC19.0268)

Identifier Type: -

Identifier Source: org_study_id

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