NCT04208971已完成不适用
Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,225
- 试验地点
- 1
- 主要终点
- Diagnosis of Atrial Fibrillation as Detected by Patch Application
研究概览
简要总结
This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Had a 10-second 12-lead ECG done at Mayo Clinic
- •Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3
排除标准
- •Diagnosed atrial fibrillation or atrial flutter
- •Missing date of birth or sex in the electronic health record (EHR)
- •A history of intracranial bleeding
- •A history of end-stage kidney disease
- •Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
- •Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.
结局指标
主要结局
Diagnosis of Atrial Fibrillation as Detected by Patch Application
时间窗: Three Months
The data will be used to examine the performance of the algorithm in detecting unrecognized atrial fibrillation (e.g. positive predictive value, negative predictive value, sensitivity, specificity, and area under the curve \[AUC\]).
次要结局
未报告次要终点
研究者
研究点 (1)
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