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Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence

Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05028686
Acronym
PROBE AI
Enrollment
500
Registered
2021-08-31
Start date
2019-02-01
Completion date
2029-09-30
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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.

Detailed 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.

Interventions

OTHERNo intervention

Observational cohort

Sponsors

Ted Rogers Centre for Heart Research
CollaboratorUNKNOWN
Peter Munk Cardiac Centre
CollaboratorUNKNOWN
Vector Institute for Artificial Intelligence
CollaboratorUNKNOWN
Institute for Clinical Evaluative Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular readmission30 dayNon-elective readmission to hospital for a cardiovascular cause
Heart failure readmission30 dayNon-elective readmission to hospital for heart failure

Secondary

MeasureTime frameDescription
All-cause readmission30-dayNon-elective readmission to hospital for a any reason
Mortality30-dayAll-cause death
Cardiovascular death30-dayDeath from cardiovascular causes

Countries

Canada

Contacts

Primary ContactDouglas S Lee, MD, PhD
dlee@ices.on.ca4163403861
Backup ContactSuzanne Perrett
suzanne.perrett@ices.on.ca4164804055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026