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临床试验/NCT02860260
NCT02860260已完成不适用

Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Measurement of plasma levels of BDNF

研究概览

简要总结

The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.

The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part
  • Patients aged 18 years or older
  • Patients who have suffered a de novo recent ischemic stroke < 12 hours
  • Patients who had cerebral imaging (CT-Scan or MRI)
  • Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20

排除标准

  • Patients without national health insurance cover
  • Patients with a clinical history of stroke
  • Patients with cerebral or sub-arachnoid haemorrhage
  • Patients with a transient ischemic attack
  • Time of symptom onset unknown
  • Patients with severe aphasia at the time of the ischemic stroke defined by a sub-score for item 9 (best language) of the NIHSS ≥ 2
  • Patients with dementia prior to the ischemic stroke
  • Patients with a significant loss of autonomy prior to the ischemic stroke, defined by a Rankin score ≥ 4
  • Patients with aphasia before the ischemic stroke
  • Patients with a contra-indication for cerebral MRI
  • Pregnant or breast-feeding women
  • Adults under guardianship
  • Subjects in custody
  • Patients who do not speak French

研究组 & 干预措施

Patients with fibrinolysis

Experimental

干预措施: Blood samples (Biological)

Patients with fibrinolysis

Experimental

干预措施: Cerebral MRI (Other)

Patients without fibrinolysis

Placebo Comparator

干预措施: Blood samples (Biological)

Patients without fibrinolysis

Placebo Comparator

干预措施: Cerebral MRI (Other)

结局指标

主要结局

Measurement of plasma levels of BDNF

时间窗: Change from baseline at Day1, Day 7 and Month 3

Measurement of serum levels of BDNF

时间窗: Change from baseline at Day1, Day 7 and Month 3

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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