NCT05923359Enrolling By Invitation不适用
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 2,000
- 试验地点
- 1
- 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
研究组 & 干预措施
Apple Watch Intervention Group
Experimental
Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team.
干预措施: Apple Watch (Other)
Control Group
No Intervention
Participants will receive usual care.
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 (1)
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