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临床试验/NCT02534532
NCT02534532撤回不适用

Atrial Fibrillation Screening With a Smartphone Device and iECG Application

Bayer0 个研究点开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Bayer
主要终点
Number of patients screened in whom the screening device detect an abnormal cardiac rhythm

研究概览

简要总结

Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool?

Objectives:

Detection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an opportunistic screening program using a smartphone device/application

  1. Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older
  2. Correlate screened patients cardiovascular risk profile and those that register cardiac rhythm irregularities for a better description of the general characteristics of Colombian population

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Females and males patients ≥65 years old attending primary care counselling
  • Written informed consent

排除标准

  • Patients with confirmed diagnosis of AF
  • Patients who do not want to participate
  • Patients consulting for acute conditions
  • Patients presenting any diagnosed arrhythmia different than AF

结局指标

主要结局

Number of patients screened in whom the screening device detect an abnormal cardiac rhythm

时间窗: Up to 6 months

Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG

时间窗: Up to 6 months

次要结局

  • Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG(Up to 6 months)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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