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临床试验/NCT04250220
NCT04250220Unknown不适用

eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)

LMU Klinikum2 个研究点 分布在 1 个国家目标入组 4,400 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,400
试验地点
2
主要终点
Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation

研究概览

简要总结

Atrial fibrillation (AF) is the most common arrhythmia in western countries and causes of up to one quarter of ischemic strokes. The randomized eHealth-based Bavarian Alternative Detection of Atrial Fibrillation study (eBRAVE-AF) tests the efficacy of an e-health based strategy for the detection of AF. The e-health-based strategy consists of a smartphone-based photophlethysmographic (PPG) screening and an ECG-based validation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • policy holders of a large health insurance company
  • age ≥50 years
  • CHA2DS2-VASc ≥1 (females ≥2)

排除标准

  • atrial fibrillation
  • oral anticoagulation

结局指标

主要结局

Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation

时间窗: 6 months

次要结局

  • Number of participants with newly prescribed oral anticoagulation(6 months)
  • Number of participants with thromboembolic events(6 months)
  • Number of participants with newly diagnosed atrial fibrillation(6 months)
  • Number of participants with stroke(6 months)

研究者

发起方
LMU Klinikum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Axel Bauer

Prof. Dr.

LMU Klinikum

研究点 (2)

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