Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence

Heart Failure Clinical Trial

— PROBE AI  

Official title:

Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028686
• Other study ID #: 4
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: September 30, 2029

Study information

• Verified date: August 2021
• Source: Institute for Clinical Evaluative Sciences
• Contact: Douglas S Lee, MD, PhD
• Phone: 4163403861
• Email: dlee[@]ices.on.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• No intervention
Observational cohort

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Institute for Clinical Evaluative Sciences	Peter Munk Cardiac Centre, Ted Rogers Centre for Heart Research, Vector Institute for Artificial Intelligence

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular readmission	Non-elective readmission to hospital for a cardiovascular cause	30 day
Primary	Heart failure readmission	Non-elective readmission to hospital for heart failure	30 day
Secondary	Mortality	All-cause death	30-day
Secondary	Cardiovascular death	Death from cardiovascular causes	30-day
Secondary	All-cause readmission	Non-elective readmission to hospital for a any reason	30-day