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临床试验/NCT05028686
NCT05028686招募中不适用

Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence

Institute for Clinical Evaluative Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Heart failure readmission

研究概览

简要总结

This study is a prospective registry that aims to predict readmissions in patients with heart failure, using -omics, machine learning, patient reported outcomes, clinical data and other high-dimensional data sources.

详细描述

There is substantial need to better predict outcomes across the spectrum of heart failure (HF) phenotypes in order to provide more efficient care with greater precision. Specifically, no validated methods have been adopted to predict outcomes reflecting transitions in health status across the continuum of HF and changes in cardiac function. A key transition is hospitalization - either readmission or de novo cardiovascular hospital admission. This is a major unmet health care need, to be able to better predict who will require hospital admission.

Novel contributions of biomarkers, -omics, remote patient monitoring, and artificial intelligence (AI). It is anticipated that prediction of readmission and many other outcomes will be further improved by measurement of circulating biomarkers and by incorporating methods from AI including machine learning and probabilistic generative models that can incorporate the lens of how physicians and patients think. Machine learning that incorporates many different types of data, including physician interpretation and a broad array of biomarker/-omics molecular information can lead to significant improvements in predictive accuracy. Novel multimarker strategies coupled with machine learning may enable the ability of physicians to predict a range of outcomes (e.g., transitions in HF health status and LVEF) and refine clinical prediction models. Furthermore, the investigators will collect patient data, including patient reported outcome measures (PROMs), and physiological data (e.g. heart rate, blood pressure, and daily weights data) and integrate these data points into predictive models. The investigators will use the PROMs obtainable using Medly as a predictor of hospitalization, and as an outcome. In this proposal, the investigators will take advantage of recent advances in both deep and high throughput proteomics technologies to perform high-resolution analyses. These novel factors can be integrated into new electronic algorithms to improve HF care in the population.

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

入选标准

  • Any patient aged 18 years or older admitted to hospital or seen in the emergency department with heart failure defined clinically
  • The diagnosis will be guided by the Framingham criteria for HF and/or BNP. A BNP >400 will be defined as definite heart failure and BNP 100-400 classified as possible heart failure.
  • Provides informed consent

排除标准

  • Patients who cannot communicate due to dementia or severe cognitive deficits
  • non-Ontario residents
  • nursing home residents
  • those who are not discharged home but are discharged to a skilled nursing facility (long-term care or chronic institution)
  • those who are unable to communicate who do not have a proxy (e.g. spouse or close family member) to facilitate communication with the patient.

结局指标

主要结局

Heart failure readmission

时间窗: 30 day

Non-elective readmission to hospital for heart failure

Cardiovascular readmission

时间窗: 30 day

Non-elective readmission to hospital for a cardiovascular cause

次要结局

  • Cardiovascular death(30-day)
  • Mortality(30-day)
  • All-cause readmission(30-day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Lee

Senior Scientist

Institute for Clinical Evaluative Sciences

研究点 (1)

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