Early Prediction of Major Adverse Cardiovascular Event Surrogates Using Remote Monitoring With Biosensors, Biomarkers, and Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Use of biomarkers (BNP and Troponin), PROs and PRIs, to predict a MACE event
研究概览
简要总结
Usual care may not identify subtle clinical changes that precede a major adverse cardiovascular event (MACE). Therefore investigators will explore the effectiveness of using biomarkers, patient reported outcomes (PROs), and patient reported informatics (PRIs) as predictors to a MACE event.
详细描述
Accurate assessment of cardiovascular risk is essential for clinical decision making in that the benefits, risks, and costs of alternative strategies must be weighed ahead of choosing the best treatment for individuals. Existing multivariable risk prediction models are vital components of current practice, and remain the logical standard to which new risk markers must be added and compared.7 The study described herein applies a practical framework for assessing the value of novel risk markers identified through patient reported outcomes (PROs), patient reported informatics (PRIs),8 and biomarkers in the forms of proteins and lipids. Though the purpose of the study is largely exploratory, it does take preliminary steps toward answering the question: "Do new PRO-, PRI-, and/or bio-markers add significant predictive information beyond that provided by established cardiac risk factors?" STUDY AIMS Aim 1: To measure cross-sectional correlations between PRIs, PROs, MACE biomarker candidates, and established MACE biomarker surrogates known to closely predict MACE itself (e.g. ultra-high sensitive troponin I [u-hsTnI], brain natriuretic peptide [BNP], and high sensitivity C-reactive protein [hsCRP], assay 1).
Hypothesis 1: PRI metrics, PRO measure scores, and Candidate Biomarkers will correlate with MACE biomarker surrogates.
Justification: Usual care may not identify subtle clinical changes that precede MACE. In order to justify future efforts to employ remote monitoring at scale to predict MACE, we will first evaluate for evidence of basic, cross-sectional correlations between PRIs, PROs, and known MACE surrogate biomarkers.
Aim 2: To measure the longitudinal relationship between PRI metrics, PRO measure scores, Candidate Biomarkers, and changes in MACE surrogates.
Hypothesis: Changes in PRI metrics, PRO measure scores, and candidate biomarkers will predict changes in MACE biomarker surrogates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18 years or older
- •Patient with history of Ischemic Heart Disease
- •Access to iOS or Android device
- •Ambulatory
排除标准
- •Patient with planned revascularization or valve surgery
- •Patients with acute coronary syndrome
- •Patients with psychiatric or substance abuse
结局指标
主要结局
Use of biomarkers (BNP and Troponin), PROs and PRIs, to predict a MACE event
时间窗: 18 months
The outcome of interest for this study is MACE, which investigators define as a composite outcome of events including: death (all cause), non-fatal MI, non-fatal stroke, or hospitalization for heart failure. Investigators will generate subject-specific monthly summary scores for the PRI and PRO metrics. Analysis of PRO's, PRIs, and biomarker surrogates will be completed using Pearson correlations. To adjust for known risk markers of MACE, investigators will run linear regressions with levels of biomarker surrogates as individual outcomes.
次要结局
未报告次要终点
研究者
Brennan Spiegel
Principal Investigator
Cedars-Sinai Medical Center