Real-World Evaluation of Eko Algorithms in a Point of Care Setting
Study Details
Study Description
Brief Summary
The purpose of this research is to prospectively test and validate the utility of Eko AI plus EMAS murmur characterization algorithm in a real world, point-of-care setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation.
In November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late.
Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021.
This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Significantly Higher Risk of Developing VHD based on Medical History History of at least one of the following: hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography. |
Device: Use of Eko CORE and Eko DUO electronic stethoscope
Auscultation of heart sounds using electronic stethoscopes
|
| Patients without Significantly Higher Risk of Developing VHD based on Medical History No history of hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography. |
Device: Use of Eko CORE and Eko DUO electronic stethoscope
Auscultation of heart sounds using electronic stethoscopes
|
Outcome Measures
Primary Outcome Measures
- Discovery Rates of Eko's algorithms [02/20/2022 - 05/20/2022]
False and true discovery rates of Eko's algorithms for detecting new clinically significant valvular heart disease, and atrial fibrillation
- Discovery Rates of point-of-care physician's outpatient visit [02/20/2022 - 05/20/2022]
False and true discovery rates of a point-of-care physician's outpatient visit for detecting new clinically significant valvular heart disease
Secondary Outcome Measures
- Sensitivity and Specificity [02/20/2022 - 05/20/2022]
Sensitivity and specificity of Eko's murmur detection algorithm relative to echocardiographic ground truth and physician auscultation ground truth
- Performance of the machine algorithm vs. the physician [02/20/2022 - 05/20/2022]
Performance of the machine algorithm vs. the physician
- Number of cardiac tests and consultations ordered [02/20/2022 - 05/20/2022]
Number of cardiac tests and consultations ordered
- Predictive Values [02/20/2022 - 05/20/2022]
Positive predictive value and negative predictive values of cardiac tests and consultations
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient consents to participation
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Willing to have heart sounds recorded with an electronic stethoscope
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Willing to undergo echocardiography
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Willing to undergo a 12-lead electrocardiography
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Adults aged 50 years and older
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Cohort 1 only: history of at least one of the following: hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
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Cohort 2 only: no history of hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
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No prior diagnosis of valve disease or heart murmur
Exclusion Criteria:
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Patient is unwilling or unable to give written informed consent
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Investigator discretion based on the best interest of the patient (e.g., experiencing a sudden, acute cardiac event)
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Under the age of 50 years old
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Prior diagnosis of valve disease or heart murmurs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pentucket Medical Associates | Haverhill | Massachusetts | United States | 01830 |
| 2 | Pentucket Medical Associates | Lawrence | Massachusetts | United States | 01843 |
Sponsors and Collaborators
- Eko Devices, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021.11