The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,075
- 试验地点
- 6
- 主要终点
- Newly identified cases of atrial fibrillation
研究概览
简要总结
Geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. Often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. Furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients.
This study applies opportunistic screening for atrial fibrillation as advised in the latest ESC Guideline on the diagnosis and management of atrial fibrillation. Furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.
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
- 否
入选标准
- •All newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including Fall clinic, Memory clinic, Pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician).
排除标准
- •The patient has a pacemaker or implantable cardioverter defibrillator.
- •The patient is known with a severe dementia, MoCA ≤ 15 points.
- •The patient has a severe tremor, from whatever cause, and thus is unable to use the PPG based smartphone AF detection algorithm.
结局指标
主要结局
Newly identified cases of atrial fibrillation
时间窗: The first 6 months after recruitment for the study
PPG or ECG detected new cases of atrial fibrillation
次要结局
- Major bleeding(From recruitment until 3 years after the recruitment of the last participant)
- Stroke(From recruitment until 3 years after the recruitment of the last participant)
- Death(From recruitment until 3 years after the recruitment of the last participant)
- Cognitive disorder(From recruitment until 3 years after the recruitment of the last participant)
- New Atrial Fibrillation, developed after the screening period(From recruitment until 3 years after the recruitment of the last participant)