Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT
Tulane University
Summary
This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.
Description
The central hypothesis in the HEARTBEAT project posits that cardiovascular events are preceded by abnormalities in biometric signals obtained from a smartwatch. These abnormalities may include, but are not limited to, patterns of heart rate, heart rate variability, oxygen saturation, as well as raw PPG signals. By leveraging advanced analytics and machine learning algorithms on smartwatch-derived biometric data, the investigators plan to identify patterns and markers that signal an increased cardiovascular disease risk. The study will use an end-to-end decentralized approach for data collecti…
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke/Transient Ischemic Attack (TIA), or diabetes mellitus). * Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study). Exclusion Criteria: * Participants who cannot read, speak, and/or understand English. * Participants with cognitive impairments who are unable to give informed consent or sig…
Interventions
- OtherSmartwatch
Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)
Locations (3)
- East Jefferson General HospitalNew Orleans, Louisiana
- Tulane University Medical Group ClinicsNew Orleans, Louisiana
- University Medical CenterNew Orleans, Louisiana