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临床试验/NCT05444335
NCT05444335进行中(未招募)不适用

Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Anticoagulant use for prevention of stroke

研究概览

简要总结

Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study.

详细描述

Atrial fibrillation or irregular heart beat is seen in 1/3rd of patients that present with stroke. Atrial fibrillation is being increasingly seen in women older than 70 as women are likely to live longer. Women are more likely to die from atrial fibrillation related stroke and are more likely to have symptoms from uncontrolled atrial fibrillation. They are also less likely to be treated with blood thinners to prevent stroke. This section of the population has been underrepresented in other studies on atrial fibrillation and the aim of this study is to proactively screen women older than 70 who are at risk for atrial fibrillation by using a wearable cardiac monitor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
70 Years 至 100 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • No previous diagnosis of atrial fibrillation
  • Age ≥70 years
  • CHA2DS2-VASc score ≥4

排除标准

  • Life expectancy < 2 years
  • Dementia or other neurologic condition which would make outpatient follow-up difficult
  • CHA2DS2-VASc score ≤3
  • Any compliance issues - such as heavy alcohol/drug use that would impede follow up.

研究组 & 干预措施

Intervention arm

Other

Women older than 70 who would wear the Zio patch for 2 weeks

干预措施: Wearable cardiac monitor -Zio patch (Device)

结局指标

主要结局

Anticoagulant use for prevention of stroke

时间窗: 2 years

Rate of anticoagulant prescription

Rate of detection of atrial fibrillation

时间窗: 1 year

Percentage of women older than 70 found to have atrial fibrillation one year from enrollment

次要结局

  • Device adherence(1 year)

研究者

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

Prachi Mehndiratta

Assistant Professor

University of Maryland, Baltimore

研究点 (1)

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