跳至主要内容
临床试验/NCT04135872
NCT04135872已完成不适用

Relationship Between Baseline Serum Albumin Level and Cognitive Impariment in Mild Acute Ischemic Stroke

Dongguan People's Hospital1 个研究点 分布在 1 个国家目标入组 435 人开始时间: 2017年1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
435
试验地点
1
主要终点
PSCI

研究概览

简要总结

This registration enrolled patients with acute ischemic stroke within 72 hours after stroke ictus. Patients was identified as first-ever stroke based on past medical histrory. Admission CT was conducted to exclude hemorrhagic stroke, but not those bleeding transformation after ischemia injury. Baseline characteristics, including demographics, vascular risk factors, lab tests and neuroimagings were collected. Patients were followed up for cognitive assessments.

详细描述

This is a perspective stroke registry cohort study. Stroke patients were included if :(1) acute first-ever ischemic stroke and admitted within 72 hours after onset; (2) clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ; (3) presented with mild stroke severity ( admission NIHSS score ≤5); (4) age between 40 and 80 years.

Clinical data including demographic characteristics, risk factors, and baseline NIHSS score were assessed and collected using a standardized table by experienced neurologists. Lab tests were performed with fasting venous blood samples within 18 hours of admission.

Patients were followed up for 6 months. The cognitive functions were assessed using the Chinese version of Montreal Cognitive Assessment (MoCA).

Contributing factors to post-stroke cognitive impariment (PSCI) were determined by comparing clinical data between PSCI and non-PSCI groups. All potential confounders were introduced into the multivariate regression models.

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

入选标准

  • acute first-ever ischemic stroke and admitted within 72 hours after onset;
  • clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (DW-MRI), those with isolated posterior circulations infarcts were exclude ;
  • presented with mild stroke severity ( admission NIHSS score ≤5);
  • age between 40 and 80 years.

排除标准

  • Patients with index cognitive impairment or under current anti-dementia or psychiatric medication;
  • patients with large infarcts (≥1/3 middle cerebral artery territory);
  • patients with severe language or physical disability that impede neuropsychological testing;
  • patients with recurrent transient ischemic attack (TIA)/stroke during follow-up;
  • coexisting serious conditions known to impair cognitive function

结局指标

主要结局

PSCI

时间窗: 6 months post-stroke

Patients with a MoCA score of \<24 were categorized as having PSCI

次要结局

未报告次要终点

研究者

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

Zhu Shi

Deputy Director of Neurology

Dongguan People's Hospital

研究点 (1)

Loading locations...

相似试验

Hypoalbuminemia in Mild Acute Stroke and Cognitive... | 临床试验