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临床试验/NCT01926691
NCT01926691已完成不适用

Predictors for Poststroke Outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) Study

Eli Sprecher, MD1 个研究点 分布在 1 个国家目标入组 575 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
575
试验地点
1
主要终点
dementia/cognitive decline occurrence

研究概览

简要总结

Background: Recent studies have demonstrated that even mild stroke survivors experience residual damage, which persists and in fact increases in subsequent years. About 45% of stroke victims remain with different levels of disability. While studies on cognitive impairment and dementia after stroke are receiving increasing clinical attention, the underlying pathophysiology is poorly understood. Identifying the mechanisms involved and recognizing early biomarkers for individual vulnerability, require a multi-modal approach, as the mechanisms involved in cerebrovascular disease and individual trajectories of post-stroke recovery may impact upon each other on various levels.

Aims and Hypothesis: To date there is no single measure that can be used to identify patients who are prone to develop cognitive impairment and other disabilities from those with better recovery prospects.

We hypothesize that data based on biochemical, neuroimaging, genetic and psychological measures can, in aggregate, serve as better predictors for subsequent disability, cognitive and neurological deterioration, and suggest possible interventions.

Design: The TABASCO (Tel-Aviv Brain Acute Stroke Cohort) study, a prospective cohort study aim to recruit about approximately 1125 consecutive first-ever mild-moderate stroke patients. It is designed to evaluate the association between predefined demographic, psychological, inflammatory, biochemical, neuro-imaging and genetic markers, measured during the acute phase, and long-term outcome: subsequent cognitive deterioration, vascular events (including recurrent strokes), falls, affective changes, functional everyday difficulties and mortality.

Discussion: This study is an attempt to comprehensively investigate the long term outcome of mild-moderate strokes. Its prospective design will provide quantitative data on stroke recurrence, the incidence of other vascular events and the evaluation of cognitive, affective and functional decline. Identifying the factors associated with post stroke cognitive and functional decline could potentially yield more effective therapeutic approaches.

The investigators believe that an extensive approach of analyzing the interaction between different risk factors would more accurately predict neurological and cognitive deterioration.

详细描述

The primary aim of the TABASCO study is to identify predictors of post stroke cognitive decline. A particular focus will be on inflammatory and stress markers, as well as neuroimaging measures.

Eligibility

Participants are recruited from patients admitted to the Department of Emergency Medicine at the Tel-Aviv Sourasky Medical Center (TASMC) within 72 hours of their first-ever acute ischemic stroke or transient ischemic attack (TIA) symptoms onset.

Criteria

Inclusion Criteria:

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 years
  • Israeli residents
  • Acute stroke that occurred within the last 3 days as defined by:
  • acute focal neurological deficit, with a total score on the NIH Stroke Scale (NIHSS) <17
  • Written informed consent by patient prior to study participation
  • Willingness to participate in follow-up

排除标准

  • patients presenting with a primary hemorrhagic stroke (intracerebral or subarachnoid)
  • history of any preceding cerebral vascular event (excluding TIA)
  • imminent death or unconscious state
  • patients unlikely to be released from hospital following the qualifying stroke, or have a severe disability after the
  • qualifying stroke which makes follow-up unlikely
  • known malignant disease or other chronic disease with poor prognosis (predicted survival less than two-years)
  • stroke resulting from trauma or invasive procedure
  • patients with a prestroke history consistent with dementia, or cognitive impairment before the stroke
  • severe aphasia.

结局指标

主要结局

dementia/cognitive decline occurrence

时间窗: 10 years

This evaluation will be based on a neurological and general clinical examination, as well as an interview with the patient's family, by a cognitive neurologist, and a senior clinician to determine whether the participant meets the DSM IV criteria for dementia or is defined as minimal cognitive impairment (MCI).

次要结局

  • dementia or cognitive decline occurrence(6 months - 10 years)

研究者

发起方
Eli Sprecher, MD
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Eli Sprecher, MD

Director of Research and Development

Tel-Aviv Sourasky Medical Center

研究点 (1)

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