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临床试验/NCT05653141
NCT05653141招募中不适用

Prediction of Post-stroke Cognitive Decline and Dementia: Impact of Cognitive Reserve and Post-stroke Life Style

Roza Umarova2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
2
主要终点
Number of participants with delayed cognitive deterioration (DCD)

研究概览

简要总结

Present study aims to track the post-stroke cognitive trajectories and to investigate its inter-individual variability.

详细描述

The study aim is to establish a model capturing patients' inter-individual variability in susceptibility to stroke damage to predict stroke-induced cognitive trajectories. This is a prospective longitudinal observational national monocentric study for 6 years (recruitment during the first 3 years). The investigators perform comprehensive neuropsychological testing in i) acute stroke phase (0-10 days post-stroke), ii) sub-acute stroke phase (3 months post-stroke), and iii) chronic stroke phase (12 months and 3 years post-stroke). At each time point, cognitive performances as well as clinical and functional status will be assessed. Furthermore, the investigators will assess the proxies of cognitive reserve and the level of post-stroke physical activity.

Analyses of the longitudinal dataset, including follow-up assessments up to 36 months post-stroke, indicated an attrition rate of up to 50%, partly attributable to post-stroke mortality. This level of attrition resulted in a substantial reduction in effective sample size and, consequently, insufficient statistical power for the planned prediction models and independent validation analyses. In particular, the reduced number of complete cases limited the robustness and generalizability of the findings. Therefore, following a recruitment pause on 02.10.2023, patient recruitment was resumed on 05.08.2025 after securing additional funding and dedicated study personnel to ensure adequate sample size for model development and validation.

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

  • Age ≥18 years old
  • First-ever anterior circulation ischemic stroke confirmed by routine MRI
  • Time of enrollment: ≤ 10 days from stroke onset.

排除标准

  • Previous stroke anamnestic or based on clinical imaging
  • Additional stroke in posterior circulation
  • Conditions that preclude the cognitive testing (e.g. delirium, intubation, reduced vigilance
  • Neurological or psychiatric conditions that preclude the data interpretation (e.g. pre-stroke dementia, schizophrenia, brain tumor, regular intake of benzodiazepine, depression)
  • MRI contraindication
  • Native language other than German, French or Italian

研究组 & 干预措施

Stroke patients

Adults with first-ever anterior circulation stroke

结局指标

主要结局

Number of participants with delayed cognitive deterioration (DCD)

时间窗: at 3 months, at 12 months and at 36 months post-stroke

The investigators will assess number of participants with deterioration of the cognitive performance in ≥2 cognitive domains on ≥ 1 Standard Deviation (1 SD).

Number of participants with delayed functional deterioration

时间窗: at 3 months, at 12 months and at 36 months post-stroke

The investigators will assess number of participants with deterioration of functional disability will be defined as decrease in disability level to one point assessed via modified Rankin Scale (mRS, 0-6, whereas 0=no functional disability).

次要结局

  • Number of participants with post-stroke cognitive impairment(10 days post-stroke, 3 months, 12 months and at 36 months post-stroke)

研究者

发起方
Roza Umarova
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Roza Umarova

PD Dr., Principal Investigator, Head of out-patient clinic of cognitive neurology

Insel Gruppe AG, University Hospital Bern

研究点 (2)

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