A protocol integrating remote patient monitoring patient reported outcomes and cardiovascular biomarkers

Chrisandra Shufelt,Shivani Dhawan,Garth Fuller,Qin Fu,Brennan Spiegel,Irene Van Den Broek,Corey W Arnold,Kelly N Mouapi,Mayra Lopez,Jennifer E Van Eyk,Sandy Joung,Mitra Mastali,Eldin Dzubur,C Noel Bairey Merz,William Speier

doi:10.1038/s41746-019-0145-6

Abstract

We describe the protocol, design, and methodology of the Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE-MACE) study as a multicomponent remote patient monitoring in cardiology. Using biosensor, biomarkers, and patient-reported outcomes in participants with stable ischemic heart disease, the PRE-MACE study is designed to measure cross-sectional correlations and establish the ability of remote monitoring to predict major adverse cardiovascular event (MACE) biomarkers and incident MACE at baseline and 12-month follow-up. It will further assess the adherence and cost-effectiveness of remote monitoring and blood sampling over the initial months. Despite medication and lifestyle changes, patients with cardiovascular disease can experience MACE due to undertreatment, poor adherence, or failure to recognize clinical or biochemical changes that presage MACE. Identifying patients using remote monitoring to detect MACE forerunners has potential to improve outcomes, avoid MACE, and reduce resource utilization. Data collection will include: (1) continuous remote monitoring using wearable biosensors; (2) biomarker measurements using plasma and at-home micro-sampling blood collection; and (3) patient-reported outcomes to monitor perceived stress, anxiety, depression, and health-related quality of life. Two hundred participants will be followed for 90 days with a subset (n = 80) monitored for 180 days. All participants will be followed up for MACE at 12 months.The PRE-MACE study will utilize remote monitoring with biosensors, biomarkers, and patient-reported outcomes to identify intermediate biomarkers of MACE in patients with stable ischemic heart disease. If shown to be effective, this intervention can be utilized between health visits to predict MACE and reduce financial impact of MACE.

Highlights

Ischemic heart disease (IHD) is the leading cause of death in the United States in men and women across all ethnicities.[1]
For individuals already diagnosed with IHD, secondary prevention focuses on controlling blood pressure, cholesterol, and often diabetes, which is managed within the confines of a health care provider’s clinical setting
Participants with stable IHD and intermediate risk for major adverse cardiovascular event (MACE), defined as an annualized MACE risk of 10–13%,7 will be recruited. Despite lifesaving medications, such as cholesterol-lowering statins, blood pressure medications, intensive antiplatelet therapy, and revascularization strategies, many stable IHD patients progress to MACE due to undertreatment, poor adherence to treatment, or failure to recognize clinical or biochemical changes that occur prior to MACE in order to deploy intervention

Summary

Introduction

Ischemic heart disease (IHD) is the leading cause of death in the United States in men and women across all ethnicities.[1]. Remote patient activity monitoring focused on stable IHD, we view it as a model for conducting During a baseline visit, participants will be provided a Fitbit population-based precision health remote monitoring research for Charge 2 device (Fitbit Inc., San Francisco, CA, USA), a wrist-worn any chronic disease.

Results

Conclusion