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临床试验/NCT02077582
NCT02077582Unknown不适用

Longitudinal Observation of Brain Ischemia and Blood Brain Barrier Permeability in the Acute Phase of Ischemic Stroke

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
410
试验地点
1
主要终点
clinical outcome measured with the modified Rankin Scale (mRS)

研究概览

简要总结

The objective of this trial is to visualize blood brain barrier function and metabolic changes in the first days after ischemic stroke with new investigational MRI sequences.

详细描述

In this study the investigators will be examining acute ischemic stroke patients on the first and second day after symptom onset using repetitive MRI examinations to visualize blood brain barrier function and metabolic changes of the brain in 5 sub-projects, each containing a specific MRI protocol with one of the following new MRI sequences:

  1. T1-Dynamics (measuring disruptions of the blood-brain barrier)
  2. pH-imaging (measuring metabolic changes, acidosis)
  3. Resting-state MRI (measuring changes in the cerebral perfusion)
  4. Quantitative MRI-Angiography (quantification of blood flow in single vessels)
  5. Diffusion Tensor Imaging (DTI) for patients with Anterior Choroidal Artery (AChA)-Infarcts (quantification of damage of white matter tracts)

Each sub-projects will be conducted in blocks of a specific time span. Morphological outcome will be assessed at day 5-7. Clinical outcome will be assessed at day 5-7 and day 90. The association of the new imaging parameter with the clinical and morphological outcome measures will be analysed. No specific intervention is assigned to the subjects by the investigators of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Suspected stroke or transient ischemic attack (TIA) within 24h from symptom onset

排除标准

  • MRI contraindication, age < 18 years, intracranial hemorrhages

结局指标

主要结局

clinical outcome measured with the modified Rankin Scale (mRS)

时间窗: on day 90

conducted as telephone interview

clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)

时间窗: on follow-up examination day 5-7

次要结局

  • final lesion volume (measured on FLAIR images)(on follow-up examination day 5-7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jochen B. Fiebach

MD

Charite University, Berlin, Germany

研究点 (1)

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