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临床试验/NCT04007757
NCT04007757已完成不适用

Recovery and Outcomes From Stroke (ROSE) Sub-study of Genetic and Environmental Risk Factors for Hemorrhagic Stroke

State University of New York at Buffalo8 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
8
主要终点
Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH)

研究概览

简要总结

The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment.

详细描述

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. More adults are affected by stroke each year than Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis or Parkinson's disease. Hemorrhagic strokes represent the most severe subtypes of stroke. An estimated 40-50% of hemorrhagic stroke victims will die and more than 80% of survivors remain disabled after hemorrhagic stroke. Yet the vast majority of analyses on outcome after stroke have focused principally on gross measures of functional outcome.

Furthermore hemorrhagic stroke differs from ischemic stroke where a loss of blood causes the area affected to be readily visible on scanning. But with hemorrhagic stroke, not only the area that we can directly see, but nearby tracts that have been compressed or stretched by the mass of the hemorrhage can be injured.

The investigators propose to follow-up on 500 cases of deep and lobar ICH to perform serial evaluations of motor and cognitive function and advanced neuroimaging to determine predictors of recovery, progressive cognitive or functional impairment. Our proposal has the advantages of adding onto a prospective ICH study which will identify and recruit cases, ability to evaluate for the degree and impact of survival and severity biases, baseline neuroimaging which includes baseline MRI, biologic samples including genotyping for apolipoprotein E alleles and uniform phenotype definitions as well as expertise in recovery/outcome analyses, advanced neuroimaging processes and epidemiologic study. This proposal performs detailed cognitive, motor and functional assessments on cases of intracerebral hemorrhage and correlates with tractography imaging. The investigators hypothesize that unlike ischemic stroke, the mass effect of the hemorrhage itself may disrupt nearby tracts in some patients while preserving them in others and will serve as a better predictor of who may recover after ICH. This project will represent the largest number of ICH cases in which tractography imaging has been performed to date.

Specific Aim #1: Improve motor recovery prediction after supratentorial ICH by adding proportion of tract injury as measured by diffusion tensor imaging (DTI) independent of the ICH volume, location, age, gender and intraventricular hemorrhage (IVH).

Hypothesis #1a: Increasing severity of injury to corticospinal tracts in ICH patients will predict worse specific motor deficits assessed at 3-month and 6-month post-stroke.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • Age 18 years or greater, fulfillment of the criteria for Deep, Subcortical or Lobar Intracerebral Hemorrhage (ICH)
  • No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of ICH.
  • Ability of the patient or legal representative to provide informed consent

排除标准

  • Brainstem or Cerebellar ICH
  • Patients Severely Affected by the ICH, Early Mortality, Hospice, or Withdraw of Care NOT eligible for ROSE

结局指标

主要结局

Change motor recovery prediction after supratentorial intracerebral hemorrhage(ICH)

时间窗: Ongoing/completed end of August 2020

This measure will determined by adding proportion of tract injury as measured by diffusion tensor imaging(DTI) methods. Measures are independent of the presenting Glasgow Coma Scale(GCS),ICH volume,location,age,sex and intraventricular hemorrhage (IVH).The primary outcome measure will be the global motor score from the motor assessment scale(MAS) testing which includes eight areas of assessment in eight areas of motor function.The MAS evaluates performance on functional tasks using a 7-point ordinal scale(0-6) in each of eight domains-moving from supine to side lying,supine to sitting over the edge of a bed, balanced sitting,moving from sitting to standing,walking,upper-arm function,hand movements(e.g., drawing a line),and advanced hand activities(e.g. combing the back of the head) rather than isolated movements. A score of 6 on each item, or an overall score of 48 indicates optimal motor behavior, and a lower score would indicate less than optimal motor behavior.

次要结局

  • Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) with complicating intracerebral (ICH) with subsequent gait ataxia.(Ongoing/completed end of August 2020)
  • Determine the correlation of periventricular tract injury in intraventricular hemorrhage(IVH) complicating intracerebral hemorrhage (ICH) with subsequent incontinence.(Ongoing/completed end of August 2020)

研究者

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

Daniel Woo

M.D.,Professor

State University of New York at Buffalo

研究点 (8)

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