- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05028686
Predicting Readmissions Using Omics, Biostatistical Evaluate and Artificial Intelligence (PROBE AI)
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Douglas S Lee, MD, PhD
- Telefonnummer: 4163403861
- E-mail: dlee@ices.on.ca
Undersøgelse Kontakt Backup
- Navn: Suzanne Perrett
- Telefonnummer: 4164804055
- E-mail: suzanne.perrett@ices.on.ca
Studiesteder
-
-
Ontario
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Toronto, Ontario, Canada
- Rekruttering
- University Health Network
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Kontakt:
- Douglas Lee, MD, PhD
- Telefonnummer: 416-340-3861
- E-mail: dlee@ices.on.ca
-
Kontakt:
- Desana Thayaparan, BSc
- Telefonnummer: 416-340-3721
- E-mail: desana.thayaparan@uhn.ca
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Hospitalized heart failure cohort
Patients hospitalized with heart failure
|
Observational cohort
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiovascular readmission
Tidsramme: 30 day
|
Non-elective readmission to hospital for a cardiovascular cause
|
30 day
|
|
Heart failure readmission
Tidsramme: 30 day
|
Non-elective readmission to hospital for heart failure
|
30 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: 30-day
|
All-cause death
|
30-day
|
|
Cardiovascular death
Tidsramme: 30-day
|
Death from cardiovascular causes
|
30-day
|
|
All-cause readmission
Tidsramme: 30-day
|
Non-elective readmission to hospital for a any reason
|
30-day
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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