Identification of Biomarkers in Ischemic Stroke - Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
healthy controls
Stroke-free
干预措施: MRI without injection (Diagnostic Test)
Ischemic stroke patients
Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
干预措施: blood samples (Genetic)
hemorragic stroke patients
Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging
干预措施: blood samples (Genetic)
healthy controls
Stroke-free
干预措施: blood samples (Genetic)
结局指标
主要结局
Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
时间窗: 6 hours after inclusion
Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)
次要结局
- Target RNA level expression in the saliva(at inclusion)
- Targeted RNA level expression according mechanism of ischemic stroke(at 3 months)
- RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).(at 3 months)
- RNA level expression across time according growth of infarction measured at inclusion and at 3 months(inclusion and 3 months)