Trials / Completed

CompletedNCT04601415

Point of Care Artificial Intelligence Tool for Heart Failure Diagnosis

Diagnosis of Heart Failure in the Post-COVID-19 Clinic, Primary Care and Hospital Setting Using a Digital Stethoscope With Artificial Intelligence (AI) Electrocardiogram (ECG)

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,050 (actual)

Sponsor: Imperial College London · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

Detailed description

Abbreviations/acronyms: DUO-EF = prediction of ejection fraction (EF) using the Eko-DUO digital stethoscope algorithm HF = heart failure HFrEF = heart failure with reduced ejection fraction COVID-19 = coronavirus disease 2019 Eko DUO = digital stethoscope device cMRI = cardiac magnetic resonance imaging ECG = electrocardiogram AIMS To demonstrate DUO-EF can identify heart failure (HF) with reduced ejection fraction (HFrEF) post-COVID-19 where diagnosis would otherwise be missed/delayed To demonstrate DUO-EF can reliably and accurately diagnose new HFrEF in the primary care setting To further validate DUO-EF diagnostic performance at-scale against gold-standard investigations (echocardiography and cardia MRI) To measure if DUO-EF suggestive of HFrEF but with normal gold standard investigations predicts future risk of developing HFrEF Methods To demonstrate DUO-EF can identify heart failure (HF) with reduced ejection fraction (HFrEF) post-COVID-19 where diagnosis would otherwise be missed/delayed To demonstrate DUO-EF can reliably and accurately diagnose new HFrEF in the primary care setting To further validate DUO-EF diagnostic performance at-scale against gold-standard investigations (echocardiography and cardiac magnetic resonance imaging - cMRI) To measure if DUO-EF suggestive of HFrEF but with normal gold standard investigations predicts future risk of developing HFrEF DUO-EF prediction of ejection fraction in patients attending COVID-19 follow up clinic and comparison with: subsequent DUO-EF at time of gold-standard investigation for HF ejection fraction as calculated by gold-standard investigation DUO-EF prediction of ejection fraction in patients where their GP suspects new heart failure and comparison with: subsequent DUO-EF at time of gold-standard investigation ejection fraction as calculated by gold-standard investigation DUO-EF prediction of ejection fraction in unselected patients attending for echocardiography or cardiac MRI, comparing DUO-EF predicted with gold-standard calculated ejection fraction Telephone call follow-up at 24 months for all patients with DUO-EF suggestive of HFrEF but normal gold standard investigations OUTCOME MEASURES Area under curve (AUC) of DUO-EF calibrated for detection of EF below 40%; classification accuracy Positive predictive value of DUO-EF in COVID-19 clinic and GP context based on subsequent gold-standard estimation of EF; negative predictive value of DUO-EF in COVID-19 follow up cohort; positive predictive value of DUO-EF at 24 months in those with negative gold standard investigations Qualitative measurement of patient and clinical end user acceptability of Eko DUO POPULATION Group 1: Patients seen in the COVID-19 follow-up clinic (n = 400) Group 2: Patients seen in primary care with symptoms newly suggestive of heart failure (n = 400) Group 3: All-comers to echocardiography departments across Imperial College Healthcare NHS Trust (n = 1,500) Group 4: patients undergoing cardiac MRI investigation (n = 100)

Conditions

Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ECG from handheld device	Acquisition of a single-lead ECG at time of presentation to GP and at echo appointment

Timeline

Start date: 2021-02-06
Primary completion: 2021-05-27
Completion: 2021-05-27
First posted: 2020-10-23
Last updated: 2023-10-11

Locations

1 site across 1 country: United Kingdom

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04601415. Inclusion in this directory is not an endorsement.