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

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ClinicalTrials.gov Identifier: NCT04601415
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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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)

Study Design
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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)
Estimated 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

Groups and Cohorts
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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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: October 23, 2020
Last Verified: October 2020
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