Shufelt Chrisandra, Dzubur Eldin, Joung Sandy, Fuller Garth, Mouapi Kelly N, Van Den Broek Irene, Lopez Mayra, Dhawan Shivani, Arnold Corey W, Speier William, Mastali Mitra, Fu Qin, Van Eyk Jennifer E, Spiegel Brennan, Merz C Noel Bairey
1Barbra Streisand Women's Heart Center, Cedars-Sinai Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA USA.
Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, CA USA.
NPJ Digit Med. 2019 Sep 3;2:84. doi: 10.1038/s41746-019-0145-6. eCollection 2019.
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 ( = 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.
我们描述了重大不良心脏事件预测、风险与评估（PRE-MACE）研究的方案、设计和方法，该研究是一项心脏病学多组分远程患者监测研究。PRE-MACE研究利用生物传感器、生物标志物和稳定型缺血性心脏病参与者的患者报告结局，旨在测量横断面相关性，并确定远程监测在基线和12个月随访时预测重大不良心血管事件（MACE）生物标志物和新发MACE的能力。它还将在最初几个月进一步评估远程监测和血液采样的依从性和成本效益。尽管进行了药物治疗和生活方式改变，但心血管疾病患者仍可能因治疗不足、依从性差或未能识别预示MACE的临床或生化变化而发生MACE。利用远程监测识别可能发生MACE的患者，有可能改善预后、避免MACE并减少资源利用。数据收集将包括：（1）使用可穿戴生物传感器进行连续远程监测；（2）使用血浆和家庭微量采样血液收集进行生物标志物测量；（3）患者报告的结局，以监测感知到的压力、焦虑、抑郁和健康相关生活质量。200名参与者将被随访90天，其中一个子集（n = 80）将被监测180天。所有参与者将在12个月时进行MACE随访。PRE-MACE研究将利用生物传感器、生物标志物和患者报告的结局进行远程监测，以识别稳定型缺血性心脏病患者MACE的中间生物标志物。如果证明有效，这种干预措施可在就诊期间用于预测MACE并降低MACE的经济影响。
