NCT05914883进行中（未招募）不适用
The NORwegian Atrial Fibrillation Self-SCREENing
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Stroke
研究概览
简要总结
Atrial fibrillation (AF) is common, increases the risk of mortality, stroke and heart failure, and portending significant burden to patients, societal health and health economy. One of three AF cases are undiagnosed. Several methods for detection of AF exist, but most of them have major limitations and are associated with resource-demanding diagnostic workup in the speciality health care services.
详细描述
This randomized clinical trial will evaluate whether self-screening for AF with the ECG247 patch monitor will reduce AF-related morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Age ≥65 years and minimum one other risk factor for stroke according to the CHA2DS2-VASc risk score: Age ≥75 years, Diabetes, Heart failure, Hypertension, Previous stroke/TIA and/or Vascular disease
- •Informed consent for participation
排除标准
- •History of AF (self-reported)
- •Use of anticoagulation therapy
- •Pacemaker/CRT device
- •No smart phone
结局指标
主要结局
Stroke
时间窗: 5 years
percent per year
次要结局
未报告次要终点
研究者
Sigrun Halvorsen
Professor
Oslo University Hospital
研究点 (1)
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