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临床试验/NCT04917237
NCT04917237招募中不适用

Non-disabling Ischemic Cerebrovascular Event With Apathy: A Prospective Registry Trail

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Death

研究概览

简要总结

The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly increased. However, few previous studies have focused on affective impairment after transient ischemic attack (TIA) and minor stroke. Stroke survivors are often described as apathetic. Even though post-stroke apathy (PSA) affects one in three stroke patients,it has not hitherto received much attention. NICE-A is a prospective study aimed to explore the association between baseline apathy and probable incident stroke in a population-based sample of TIA and minor stroke adults.

详细描述

Transient ischemic attack (TIA) and acute minor ischemic stroke, are common and may leave impermanent or mild neurological deficit, they are termed as non-disabling ischemic cerebrovascular disease (NICE). TIA and minor stroke exhibit the common substantial risk factors for early stroke recurrence and epidemiological characteristic, with approximately 10 to 20% of patients having a stroke within 3 months after the index event.

Previous studies has shown that post-stroke apathy (PSA) affects one in three stroke patients, which is consistently associated with a worse level of functional recovery, poorer overall health and poorer quality of life. However, still little is known about the development of TIA and minor stroke patients with apathy. Thus, it is imperative to find the relationships between baseline PSA and probable incident stroke in these patients.

NICE is an attractive researching area globally. According to the large quantities of NICE patients in China and the low standardized therapeutic rate, the awareness of TIA and minor stroke is largely insufficient. The purpose of the present NICE-A study is to establish the prevalence, predictors and evolution of symptoms of PSA in TIA and minor stroke patients during the first post-stroke year.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years old Onset of a minor stroke (National Institute of Health stroke scale, NIHSS≤3) and TIA elapsed time from last episode to registry <1 month

排除标准

  • patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.
  • patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.
  • patients who received endovascular or thrombolytic therapy.

结局指标

主要结局

Death

时间窗: 12 months

Death from any cause

Stroke recurrence

时间窗: 12 months

Ischemic stroke

次要结局

  • Hemorrhagic stroke(12 months)
  • Functional outcome(12 months)

研究者

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

Bingying Du

Professor

Changhai Hospital

研究点 (1)

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