Identification of Biomarkers in Ischemic Stroke - Clinical Trial

Stroke, Ischemic Clinical Trial

— IBIS-CT  

Official title:

Identification of Biomarkers in Ischemic Stroke - Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253275
• Other study ID #: IBIS-CT (29BRC19.0268)
• Status: Completed
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: February 6, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	RNA level expression across time according growth of infarction measured at inclusion and at 3 months	Each targeted genes will be measured by quantitative rt-PCR	inclusion and 3 months
Secondary	RNA level expression across time according Rankin scale at three months dichotomized in good (= 2) and bad prognosis (> 3).	Each targeted genes will be measured by quantitative rt-PCR	at 3 months
Secondary	Targeted RNA level expression according mechanism of ischemic stroke	Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR	at 3 months
Secondary	Target RNA level expression in the saliva	For 3 participants, one of each arm, a saliva sample will be collected at inclusion.	at inclusion