None listed
Conditions
Brief summary
This study will investigate whether smartwatches can be used to diagnose heart problems early. Participants will use their smartwatches to record 12-lead electrocardiograms (ECG) similar to those done in hospitals and clinics, and also provide a snapshot of their daily physical activity for the preceding year. The purpose of this research is to see if self-recorded heart data and activity data can help in the early detection of heart disease and provide a better understanding of how physical activity affects heart health. We hypothesize that using smartwatch ECG technology for at-home heart check can lead to earlier identification of cardiovascular risks. ECG Heart Age, as a marker of increased cardiovascular risk, has the advantage of being easily understood by the patient and may provide strong incentives for life-style changes or compliance to medication. If ECG Heart Age can be obtained without the use of conventional ECG machines, but instead applied by non-health care professionals at their own home, impact may be even greater. WHO identified the need for more research on the dose-response relationship between volume and/or intensity of physical activity and health outcomes. However, accurately measuring activity volume and intensity in the general public is challenging. Whilst there are many benefits to wearable devices, there are potential confounders to measuring activity in trials and extrapolating to general exercise levels. A potential solution to this issue is through collection of objectively measured physical activity in individuals who own a smartwatch or an activity monitor.
Interventions
There is no exposure or intervention, this is an observational research. Participants will be recruited online. The study involves downloading an iPhone App that will allow recording a 12-lead ECG using an ECG enabled Apple Watch. Participants will use their own Apple Watches, access to one as an enrolment criterion. Apple Watches will not be supplied as part of this study.
The study iPhone App will guide the participants through the recording process from the comfort of their home. Ideally the
There is no exposure or intervention, this is an observational research. Participants will be recruited online. The study involves downloading an iPhone App that will allow recording a 12-lead ECG using an ECG enabled Apple Watch. Participants will use their own Apple Watches, access to one as an enrolment criterion. Apple Watches will not be supplied as part of this study. The study iPhone App will guide the participants through the recording process from the comfort of their home. Ideally they should have had a period of 10 minutes rest. The total number of recordings required is 15 recordings, at 30 seconds each, totalling 7 minutes and 30 seconds. Add roughly 10-15 minutes of preparation, we anticipate the total recording time to take 15-20 minutes in total from our experience. The resulting smartwatch ECG will be sent to the study servers for both conventional manual human analysis and Advanced ECG algorithmic analysis. Manual analysis involves visual assessment of the ECG, and is the standard read out of the ECG by qualified ECG technicians as per current clinical standards. Advanced ECG analysis uses advanced digital signal processing to derive a large number of ECG features, including vectorcardiography and wave complexity measures. These features are then combined in a multivariable machine learning model to generate scores for disease probabilities. If a number of pre-defined abnormalities are found, participants are contacted via email with all the required information to share with their GP within 30 days of recording and submitting their smartwatch ECG. Otherwise, their outcomes will be assessed via data linkage at 2 years from the date of enrolment. The primary outcomes for this particular study will be cardiovascular events at 2 years. The data linkage sources will be via the dedicated state research health data linkage such as the Centre for Health Record Linkage in NSW and ACT, and is counterparts in other states that record mortality and hospitalisation data. While the Heart Watch Study concludes after 2 years and the results published, data will remain stored indefinitely leaving the door open for further research down the track. This is clearly indicated in the HREC approved Participant Information Sheet. The Heart Age is simply another measure of Advanced ECG analysis and does not involve any extra steps or procedures on behalf of the participant. It will be done only once during the initial analysis at enrolment. The snapshot of daily activities are captured by the study A-ECG app from their Apple Health app with the user's permission. No extra interviews or steps are required on the participants' side.
Sponsors
The University of Sydney
Eligibility
Sex/Gender
All
Age
20 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Electronically obtained informed consent Individuals with access to Apple Watch series 4 or later and an iPhone and no prior known heart disease.
Exclusion criteria
Any history of existing heart disease including arrhythmia, cardiomyopathy, ischemic heart disease, history of percutaneous coronary intervention or bypass surgery, congenital heart disease, valvular disease, bundle branch blocks and implanted cardiac devices.
Outcome results
None listed