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临床试验/NCT03666897
NCT03666897已完成不适用

Markers of Recovery in StrokE Study

Corewell Health West2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年10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
21
试验地点
2
主要终点
Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes

研究概览

简要总结

Our current biological understanding of stroke recovery in humans is extremely limited and this lack of knowledge is a major challenge in reducing stroke disabilities and deficits. Evidence of neural repair in humans can be gleaned indirectly through functional outcome measures, but we propose that metabolomics may also provide a minimally invasive window into human brain repair. This study will integrate clinical imaging and molecular biomarkers as a diagnostic tool in further understanding stroke recovery mechanisms.

详细描述

Our long-term goal is to improve and hasten recovery following a stroke with translational research, which would combine the use of neuroimaging and identify neural repair metabolites. The objective and sequential step in fulfilling our long-term goal, is to identify differential expression of select stroke plasma biomarkers of neural repair, and image CST integrity in patients with good and poor recovery following an ischemic stroke. Diffusion tension imaging (DTI), will be used to image the neural repair as it occurs, further enhancing our understanding of stroke recovery. There are currently no known plasma biomarkers of neural repair. Identification of such biomarkers would be extremely valuable for designing stroke recovery drugs and timing rehabilitation therapies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Imaging confirmed ischemic stroke within 7 days of stroke onset
  • Age > 18 years
  • NIHSS ≥ 1 on arm item OR NIHSS = 0 on arm item but < 3/5 strength on MRC scale in distal joint (flex/ext elbow or grip/ext hand)
  • Pre-stroke modified Rankin Scale (mRS) < 3

排除标准

  • Active malignancy (not thought to be cured or in remission)
  • Anemia (HCT < 25)
  • Suspected bacterial endocarditis

研究组 & 干预措施

DTI Outcomes and Biomarkers

Other

Imaging and Lab Collection

干预措施: DTI Images and Plasma Biomarkers (Other)

结局指标

主要结局

Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes

时间窗: 2 years

Identify differential expression of select stroke plasma biomarkers of neural repair through metabolic testing and imaging CST integrity in patients with good and poor recovery following an ischemic stroke

次要结局

  • Change in Fugl-Meyer(Baseline, 90 days post stroke)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Markers of Recovery in StrokE Study (MORSE) | 临床试验