According to initial documentation published by Mayo Clinic today, Mayo Clinic is launching a brand new ambitious clinical study that will require a million participants.
The study ‘Evaluation of ECG transmission and AI Models Using Apple Watch ECGs and Symptoms Data collected using a Mayo iPhone App” was published on the clinical trials site today.
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The study aims 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.
- The patient ECGs and self-reported symptoms data will be uploaded to the Mayo Clinic’s AI Dashboard in the patient’s medical record (ECG rhythm classification facilitated by the Apple ECG program).
- Researchers will perform a retrospective review of electronic medical record data from enrolled subjects to assess the quality of the Apple Watch obtained ECGs, evaluate 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)
The 12-month new study will use Artificial Intelligence ECG algorithms to predict various cardiac pathologies based on the Apple Watch ECG data.
The accuracy and performance of AI algorithm models will be assessed by comparing AI-predicted diseases and patients’ given medical diagnoses in the electronic medical record.
Reference: Clinical Trial Announcement by Mayo Clinic on April 12th, 2022