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临床试验/NCT03004859
NCT03004859已完成不适用

Eine Beobachtungsstudie Zur Erfassung Von (Asymptomatischem)Vorhofflimmern Mittels Eines Gelegenheitsscreenings älteren Menschen ab 65 Jahren

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 7,606 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,606
试验地点
1
主要终点
Number of newly detected atrial fibrillation in adults from the age of 65 by means of an opportunistic screening with an ECG hand-held diagnostic tool in a pharmacy setting

研究概览

简要总结

Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an increased risk of thromboembolic stroke. The risk to suffer from AF increases with age. Early detection of AF and anticoagulation seem the most effective way of preventing ischaemic stroke in patients at risk. The guidelines of the European Society of Cardiology recommend opportunistic screening for AF by pulse check at each general practitioner visit for all patients aged 65 years or older.

The objective of this study was to test whether an opportunistic AF screening with a hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF among people in the age of 65 and older. Besides a pulse palpation with a hand-held ECG-stick the screening in the pharmacies also includes a questionnaire related to demographics and medical history of the subject as well as several questions concerning the stroke risk stratification (CHA₂DS₂-VASc). Every subject with a positive test result (indication on AF) is insistently asked to make an appointment with his or her general practitioner. The subject receives an information letter for his or her general practitioner that adverts to the positive screening result and the necessity of further diagnostic Investigation.

In order to assess the incidence of unknown AF as well as accomplish the secondary objectives of this study, two follow-ups by means of telephone interviews are performed. First, all subjects with a positive test result are called 8 weeks after the screening in the pharmacies was conducted. The subject is asked several questions concerning personal data/demographics, the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the Intervention and the mace. 12 months after the screening in the pharmacies was performed, all participating subjects were called. The list of questions is similar to the one that is used during the first telephone interviews after eight weeks.

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

入选标准

  • At least 65 years or older
  • Signed informed consent
  • Signed subject information

排除标准

  • Insufficient language skills
  • Limited cognitive abilities
  • Limited physical abilities (i.e. tremor)

结局指标

主要结局

Number of newly detected atrial fibrillation in adults from the age of 65 by means of an opportunistic screening with an ECG hand-held diagnostic tool in a pharmacy setting

时间窗: 12 months

The data is going to be collected in a screening period of two weeks in an urban pharmacy setting and a screening period of two weeks of data collection in a more rural pharmacy setting

次要结局

  • The subject's behavior change regarding diagnosis and therapy from the ECG measurement at pharmacy at 8 weeks and 12 months.(8 weeks and 12 Months)
  • Identification and description of new therapeutic measures.(12 Months)

研究者

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

Nikolaus Marx

Univ. Professor Dr. med.

RWTH Aachen University

研究点 (1)

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