EvALuation of ECG Transmission and AI moDels Using Apple Watch ECGs and Symptoms Data Collected usiNg a Mayo iPhone App
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Number of patient-triggered Apple Watch ECGs recorded
研究概览
简要总结
The purpose of the study is to determine if the Electrocardiograms (ECGs) and symptoms data obtained from an Apple Watch and transmitted to Mayo Clinic are of sufficient quality to guide a person's care.
详细描述
- Patients who have the Mayo Clinic patient app and iOS 14 or higher who are 18 years of age or older will be invited to enroll.
- Patient will undergo email survey to assess ownership of Apple Watch v4 or later, and subsequent willingness to participate in the study. Those who agree will undergo digital consent and enrollment.
- A customized Mayo Clinic Study App will be available to download to their iOS device and will be used to test whether it is feasible to access ECGs and symptoms data patients have collected using their personal Apple watch that are saved on the patient's phone. The study app will facilitate transmission of past and future patient-recorded watch ECGs.
- The patient ECGs and self-reported symptoms data will be uploaded to the AI Dashboard in the patient's medical record (ECG rhythm classification facilitated by Apple ECG program).
- We will perform a retrospective review of electronic medical record data from enrolled subjects to assess the quality of the Apple Watch obtained ECGs, assess the results from the AI-ECG dashboard using obtained watch ECGs, and compare these results to prior or subsequently obtained 12 lead ECGs.
- Data analysis will be performed with steps to ensure patient confidentiality. Data will be transmitted using similar protocols as with current app data, and all data will be saved in the secure Mayo Clinic electronic environment (called the UDP).
- All patients' watch data will be compared to AI dashboard data. Additionally, clinical data in the EMR (such as blood tests, echocardiograms, and other data recorded for routine medical care) will be used to assess the utility of the watch ECG quality for AI algorithms (such as determining whether a weak heart pump is present, for example).
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
- 是
入选标准
- •Using the Mayo patient iPhone app. (determined automatically via Mayo software).
排除标准
- •Inability to provide informed consent.
结局指标
主要结局
Number of patient-triggered Apple Watch ECGs recorded
时间窗: 12 months
Total number of patient-triggered Apple Watch ECGs recorded and uploaded by individual patients over the study period.
Number of Apple Watch ECGs of acceptable quality
时间窗: 12 months
A sample of Apple Watch ECGs will undergo manual review by ECG technicians and rated using a standard data form for signal quality and diagnostic utility, summarized as the percent of "acceptable" ECGs.
Performance of Artificial Intelligence ECG algorithms for disease prediction with Apple Watch ECGs
时间窗: 12 months
Artificial Intelligence ECG algorithms to predict various cardiac pathologies will be applied to Apple Watch ECGs. Accuracy and performance of AI algorithm models will be assessed by comparing AI predicted disease and patient's given medical diagnosis in the electronic medical record.
Frequency of medical providers accessing Apple Watch data
时间窗: 12 months
Number of times a medical provider accesses the Apple Watch data via electronic medical record-linked ECG dashboard.
次要结局
未报告次要终点
研究者
Paul A. Friedman
Principal Investigator
Mayo Clinic