Clinical trial NCT05324566: Evaluation of ECG Transmission and AI Models Using Apple Watch ECGs and Symptoms Data Collected Using a Mayo iPhone App
Official title: EvALuation of ECG Transmission and AI moDels Using Apple Watch ECGs and Symptoms Data Collected usiNg a Mayo iPhone App
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Arrhythmias, Cardiac
Health Care Utilization
Keywords: digital health
artificial intellegence
neural network
electrocardiogram
wearable device
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 4163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the general public who own ECG-capable Apple Watches

Brief summary: 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.

Detailed description: 1. 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.
2. 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.
3. 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.
4. 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).
5. 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.
6. 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).
7. 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).

Eligibility criteria: Inclusion Criteria:

- Using the Mayo patient iPhone app. (determined automatically via Mayo software).

Exclusion Criteria:

- Inability to provide informed consent.

Primary outcomes:
measure: Number of patient-triggered Apple Watch ECGs recorded
timeFrame: 12 months
measure: Frequency of medical providers accessing Apple Watch data
timeFrame: 12 months
measure: Number of Apple Watch ECGs of acceptable quality
timeFrame: 12 months
measure: Performance of Artificial Intelligence ECG algorithms for disease prediction with Apple Watch ECGs
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: