DUO-EF-19: Point of Care Artificial Intelligence Tool for Heart Failure Diagnosis
Study Details
Study Description
Brief Summary
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
Prospective observational study of left ventricular ejection fraction predicted by application of artificial intelligence to single-lead ECG acquired by a digital stethoscope; in the post-covid-19 follow up clinic, in patients presenting with heart failure symptoms in primary care, and in patients attending for echocardiography and cardiac MRI.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| GP Referrals Patients with HF referred by GP to echo department |
Diagnostic Test: ECG from handheld device
Acquisition of a single-lead ECG at time of presentation to GP and at echo appointment
|
| Echo patients Non-selected patients attending echo department in hospital |
Diagnostic Test: ECG from handheld device
Acquisition of a single-lead ECG at time of presentation to GP and at echo appointment
|
Outcome Measures
Primary Outcome Measures
- Area under receiver operating curve [up to 18 months]
Area under curve (AUC) where maximum value is '1', describing ability of algorithm to discriminate low from not-low ejection fraction
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Attendance at GP with ?HF symptoms
-
Referral from GP or elsewhere for echocardiogram in hospital
-
Age >18
Exclusion Criteria:
- Unable to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Patrik Bachtiger | London | Non-US/Non-Canadian | United Kingdom | E5 0LJ |
Sponsors and Collaborators
- Imperial College London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 285417