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临床试验/NCT02205424
NCT02205424已完成不适用

Is Stroke Neurodegenerative? A Longitudinal Study of Brain Volume and Cognitive Decline Following Stroke (CANVAS: Cognition And Neocortical Volume After Stroke).

The Florey Institute of Neuroscience and Mental Health3 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2011年5月1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
175
试验地点
3
主要终点
Difference in total brain volume between 3 month and 3 year time-points

研究概览

简要总结

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer's disease. Yet little is known about whether brain volume loss - a hallmark of dementia - occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). The hypotheses are that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

详细描述

Our primary outcome measure was total brain volume (TBV) change between the 3-month and 3-year time-points compared between stroke patients and controls.

Secondary outcome 1 was TBV change between 3-months and 3-years comparing CN and CI stroke participants. TBV at 3-months will be adjusted for CCI scores, and years of education; the latter as it is correlated with cognitive performance and post-stroke dementia risk, but not for stroke lesion volume as no conclusive evidence for an effect has been demonstrated previously.

Secondary outcome 2 was hippocampal volume (HV) change between 3-months and 3-years in stroke patients and controls with adjustments identical to primary outcome.

Secondary outcome 3 was the comparison of HV change between 3-months and 3-years comparing CN and CI stroke participants with adjustments identical to secondary outcome 1.

See published protocol and uploaded statistical analysis plan for detailed description.

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

  • Clinical stroke
  • Aged greater than 18 years;
  • Able to have cognitive testing and MRI scan; and
  • Able to give informed consent

排除标准

  • Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely;
  • Normal exclusion criteria for MRI; e.g., implanted metal, severe claustrophobia;
  • Pre-existing dementia
  • Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period
  • People in existing dependent or unequal relationships with any member of the research team, to protect against coercion

结局指标

主要结局

Difference in total brain volume between 3 month and 3 year time-points

时间窗: Between 3 months and 3 years post-stroke

We will examine changes in brain volume between the 3 month and 3 year time-points in ischemic stroke patients and healthy age-matched control participants

次要结局

  • Comparison of hippocampal volume change between 3 month and 3 year time-points in those who were cognitively normal versus cognitively impaired at 3 months post-stroke.(Between 3 months and 3 years post-stroke)
  • Comparison of total brain volume (TBV) change between 3 month and 3 year time-points in those who were cognitively normal (CN) versus cognitively impaired (CI) determined at the 3 months post-stroke time point.(Between 3 months and 3 years post-stroke)
  • Difference in hippocampal volume between 3 month and 3 year time-points in stroke and control participants.(Between 3 months and 3 years post-stroke)

研究者

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

Amy Brodtmann

Prof Amy Brodtmann

The Florey Institute of Neuroscience and Mental Health

研究点 (3)

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Cognition And Neocortical Volume After Stroke | 临床试验