Clinical trial NCT05459545: Real-World Evaluation of Eko Algorithms in a Point of Care Setting
Official title: Real-World Evaluation of Eko Algorithms in a Point of Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Murmur, Heart
Innocent Murmurs
Heart Murmurs
Pathologic Murmur
Atrial Fibrillation
Keywords: artificial intelligence
machine learning
Lead sponsor: Eko Devices, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 371
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult primary care clinic

Brief summary: The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.

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.

Eligibility criteria: Inclusion Criteria:

* Patient consents to participation
* Willing to have heart sounds recorded with an electronic stethoscope
* Willing to undergo echocardiography
* Willing to undergo a 12-lead electrocardiogram
* Adults aged 65 years and older
* 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
* No prior diagnosis of valve disease or heart murmur

Exclusion Criteria:

* Patient is unwilling or unable to give written informed consent
* Patients experiencing a known or suspected acute cardiac event
* Under the age of 65 years old
* Prior diagnosis of valve disease or heart murmurs

Primary outcomes:
measure: Sensitivity and Specificity of Eko's AI relative to ground truth
timeFrame: 02/20/2022 - 05/20/2024
measure: Sensitivity and Specificity of Eko's AI relative to PCP auscultation and ground truth
timeFrame: 02/20/2022 - 05/20/2024
measure: Positive and negative predictive values for AI detecting new VHD
timeFrame: 02/20/2022 - 05/20/2024
measure: Positive and negative predictive values for PCP detecting new VHD
timeFrame: 02/20/2022 - 05/20/2024
Secondary outcomes:
measure: Sensitivity and Specificity of Eko's AI relative to echocardiographic ground truth.
timeFrame: 02/20/2022 - 05/20/2024
measure: Performance of the machine algorithm vs. the physician
timeFrame: 02/20/2022 - 05/20/2024
measure: Number of cardiac tests and consultations ordered
timeFrame: 02/20/2022 - 05/20/2024
Other outcomes:
Locations:
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Lawrence
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Dunn
country: United States
facility: Maria Medical Center
state: North Carolina
city: Lillington
country: United States
facility: Edgewater Medical Center
state: North Carolina
city: Lillington
country: United States
facility: Hometown Medical PLLC
state: North Carolina
Study officials:
References: