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Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence (PROBE AI)

2021年8月30日 更新者:Douglas Lee、Institute for Clinical Evaluative Sciences
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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (预期的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Douglas S Lee, MD, PhD
  • 电话号码:4163403861
  • 邮箱:dlee@ices.on.ca

研究联系人备份

学习地点

    • Ontario
      • Toronto、Ontario、加拿大
        • 招聘中
        • University Health Network
        • 接触:
          • Douglas Lee, MD, PhD
          • 电话号码:416-340-3861
          • 邮箱:dlee@ices.on.ca
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 105年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Hospitalized heart failure patients

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Hospitalized heart failure cohort
Patients hospitalized with heart failure
Observational cohort

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cardiovascular readmission
大体时间:30 day
Non-elective readmission to hospital for a cardiovascular cause
30 day
Heart failure readmission
大体时间:30 day
Non-elective readmission to hospital for heart failure
30 day

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间:30-day
All-cause death
30-day
Cardiovascular death
大体时间:30-day
Death from cardiovascular causes
30-day
All-cause readmission
大体时间:30-day
Non-elective readmission to hospital for a any reason
30-day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年2月1日

初级完成 (预期的)

2024年9月30日

研究完成 (预期的)

2029年9月30日

研究注册日期

首次提交

2021年8月25日

首先提交符合 QC 标准的

2021年8月25日

首次发布 (实际的)

2021年8月31日

研究记录更新

最后更新发布 (实际的)

2021年9月2日

上次提交的符合 QC 标准的更新

2021年8月30日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 4

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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