Identification of Biomarkers in Ischemic Stroke - Clinical Trial

NCT04253275 | Completed

• 1 other identifier: IBIS-CT (29BRC19.0268)
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic

Outcome Measures

Primary Outcomes (1)

• Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion

  Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)

  6 hours after inclusion

Secondary Outcomes (4)

• RNA level expression across time according growth of infarction measured at inclusion and at 3 months

  inclusion and 3 months

• RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).

  at 3 months

• Targeted RNA level expression according mechanism of ischemic stroke

  at 3 months

• Target RNA level expression in the saliva

  at inclusion

Study Arms (3)

Ischemic stroke patients

OTHER

Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging

Genetic: blood samples

hemorragic stroke patients

OTHER

Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging

Genetic: blood samples

healthy controls

OTHER

Stroke-free

Genetic: blood samples; Diagnostic Test: MRI without injection

Interventions

blood samples 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.

Ischemic stroke patients; healthy controls; hemorragic stroke patients

MRI without injection DIAGNOSTIC_TEST

MRI at inclusion for controls

healthy controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For ischemic stroke :
• Age \> 18-year-old
• Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, France

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Interventions

Blood Specimen Collection; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging

Study Officials

• Serge TIMSIT, Pr

  serge.timsit@chu-brest.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: February 5, 2020
• Study Start: November 24, 2020
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)