NCT05923359进行中（未招募）不适用
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Atrial fibrillation
研究概览
简要总结
The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had a 10-second 12-lead ECG done at Mayo Clinic
- •Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF
- •Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3
排除标准
- •Diagnosed atrial fibrillation
- •Diagnosed dementia
- •Diagnosed end-stage kidney disease
- •History of intracranial bleeding
- •Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
- •Missing date of birth
- •Residence outside of the U.S. or missing address information
结局指标
主要结局
Atrial fibrillation
时间窗: 2 years
Number of participants diagnosed with atrial fibrillation
次要结局
- Ischemic stroke or systemic embolism events(2 years)
- Major bleeding(2 years)
- Change in individuals' maximum learning span(Baseline, 2 years)
- Change in processing speed measure(Baseline, 2 years)
- Mortality(2 years)
研究者
研究点 (2)
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