Cardiovascular disease is the leading cause of mortality in women and men. There are over 800,000 deaths annually in the United States; younger women and ethnic minorities are disproportionally underserved. Routine examinations during medical visits can identify patients that may be at increased risk, however patients spend a majority of their life away from a doctor’s office. Identifying early markers predictive for those individuals that are at an increased risk for developing cardiovascular events between visits to capture day-to-day or month-to-month changes in symptomology, biochemical biomarkers, or psychosocial behavior may potentially prevent catastrophic situations, improve access to care and reduce resource utilization.
In this paper, we describe the protocol and design of the Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE-MACE) study funded by the California Initiative for the Advancement of Precision Medicine (CIAPM), a State-wide public program designed to spur pragmatic precision medicine research. Utilizing three platforms of remote monitoring in patients with stable ischemic heart disease, the study will “fill in the blanks” by building a more complete and precise picture of disease destabilization outside the walls of a hospital or clinic. These three platforms include:
Remote Patient Activity Monitoring. Participants will be provided a Fitbit Charge 2 device (Fitbit Inc., San Francisco, CA, USA), a wrist-worn device that tracks heart rate and activity which will be worn for 3-months continuously. A subset will also receive the AliveCor KardiaMobile device (AliveCor, Mountain View, CA) and will be asked to monitor a rhythm electrocardiogram stripe weekly or if they experience any cardiac symptoms.
Biochemical Biomarker Monitoring. Remote biochemical biomarker monitoring will occur monthly using the Mitra® micro-sampling device (Neoteryx, Torrance, CA), an FDA-listed class 1 device (D254956) that allows remote, longitudinal, and volumetric blood sample collection using a simple finger prick.
Patient Reported Outcomes. To remotely monitor self-reported levels of perceived stress, anxiety, depression, and health-related quality of life. In addition to administering cardiovascular disease-targeted questionnaires, we will use the NIH Patient Reported Outcome Measurement Information System (PROMIS) to track patient-reported pain, fatigue, physical function, anxiety, and depression scores via smartphone, tablet, or desktop computer.
To summarize, this study design and protocol offers a model for conducting multidisciplinary digital health research across diverse data collection platforms. will provide the frames for future mobile health.