Eine Beobachtungsstudie Zur Erfassung Von (Asymptomatischem)Vorhofflimmern Mittels Eines Gelegenheitsscreenings älteren Menschen ab 65 Jahren
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
- 是
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
Nikolaus Marx
Univ. Professor Dr. med.
RWTH Aachen University
