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Point of Care Artificial Intelligence Tool for Heart Failure Diagnosis (DUO-EF-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601415
Recruitment Status : Unknown
Verified May 2021 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : October 23, 2020
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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
Heart Failure Diagnostic Test: ECG from handheld device

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)

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort 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




Primary Outcome Measures :
  1. Area under receiver operating curve [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care population and patients referred to echocardiography department from in/outpatient settings
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601415


Locations
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United Kingdom
Patrik Bachtiger Recruiting
London, Non-US/Non-Canadian, United Kingdom, E5 0LJ
Contact: Patrik Bachtiger    020 7589 5111    p.bachtiger@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04601415    
Other Study ID Numbers: 285417
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Identifiable data will be held within the clinical investigator team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases