跳至主要内容
临床试验/NCT02369328
NCT02369328Unknown不适用

Multimodal MRI Study of Ischemic Stroke

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
The time of stroke onset

研究概览

简要总结

Stroke is the second most frequent causes of mortality in the word after cardiovascular disease and the most frequent cause of disability. The majority of strokes are ischemic (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long term functional recovery is largely dependent from the ability of the brain to reorganize. Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke at the acute phase. However, up to now, no imaging tool is available to determine the time of stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and structural plasticity mechanisms occurring after stroke. The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset. The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke. Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • Patient having presented a cerebral infarct beforehand confirmed by the brain imaging
  • Patient having presented a cerebral infarct the hour of the beginning of which is known with certainty and dating less than 24 hours
  • Patient having presented a cerebral infarct the area(extent) of which is superior to 1,5 ml

排除标准

  • Patients presenting the usual contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
  • Patients presenting a risk of not compliance to the examination: disorders(confusions) of the elementary understanding, the confusion, the involuntary movements, the bad tolerance of the prolonged dorsal decubitus

结局指标

主要结局

The time of stroke onset

时间窗: 3 years

The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset

次要结局

  • The degree of tissue damage and brain reorganization after stroke(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Multimodal MRI Study of Ischemic Stroke | 临床试验