Smart watches and wearable devices equipped with novel sensors can provide real-time insights into the users’ health. These continuous streams of data can bear signatures of cardiovascular diseases and their risk factors, with important clinical implications for improving care. Understanding these patterns and signatures will increasingly pave the way to personalized medicine, enabling clinicians to offer tailored recommendations to their patients based on their wearable and health data.
We, at the Cardiovascular Data Science (CarDS) Lab at Yale (PI: Rohan Khera,MD MS), are conducting the PRECARDIA study, a single-arm cohort study of adult individuals seeking outpatient care across hospital and clinic locations affiliated with theYale-New Haven Health System (YNHHS), who are existing users of Fitbit electronic wearable devices.The study has been approved by the Yale Institutional Review Board(IRB) under the application/study ID2000037536(June 17th, 2024).
The study has an estimated start date in July 2024 and is expected to continue until June 2029. Eligible participants using Fitbit devices willconsent to sharing their Fitbit data with the research team. Research investigators will then access stored Fitbit data from the Fitbit API on a daily basis for all participants who have provided informedconsent. Participants will then be followed through passive review of their electronichealth records (EHR) to obtain information on their healthcare events, and prevalent and incident diagnoses. The study will explore the association between wearable-derived metrics (activity levels, step counts, ECGs etc) and prevalent and incident cardiovascular and cardiometabolic indices and diagnoses.
