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临床试验/NCT04282993
NCT04282993Unknown不适用

Wearable Devices for Secondary Prevention of Ischemic Stroke

Campus Bio-Medico University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Compliance of patients to at-home follow-up by means of wearable devices

研究概览

简要总结

Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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 greater than or equal 50 years
  • Recent transient ischemic attack or minor stroke

排除标准

  • Patients with significant cognitive impairment
  • Patients dependent in the instrumental activities of daily life
  • Patients not able to respect the frequency of monitoring program
  • Patients with history of atrial fibrillation

结局指标

主要结局

Compliance of patients to at-home follow-up by means of wearable devices

时间窗: 1 month

Number of measurements actually performed in comparison to number of expected measurements

次要结局

  • Atrial fibrillation Detection Rate(1 month)
  • Prevalence of Recurrent Stroke or Transient Ischemic Attack(1 month)

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Di Lazzaro Vincenzo

Head of Neurology

Campus Bio-Medico University

研究点 (2)

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