Clinical trial NCT05176899: Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting
Official title: Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Murmur, Heart
Innocent Murmurs
Heart Murmurs
Pathologic Murmur
Keywords: artificial intelligence
machine learning
Lead sponsor: Eko Devices, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be screened by MedStar study personnel for eligibility from the onsite primary, internal medicine, and geriatric clinics at MedStar. If a patient meets all of the inclusion criteria, and none of the exclusion criteria, they will be approached for participation.

Brief summary: The purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur Analysis Software) on a clinician's referral decision in a real-world primary care setting. There is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram.

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 June 2022, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko Murmur Analysis Software" (EMAS), a set of machine learning algorithms that are able to screen signal quality and identify fundamental heart sounds, distinguish structural murmurs from absent or innocent murmurs, and provide a structural murmur's timing in the cardiac cycle.

This study sets out to evaluate the impact of EMAS on a clinician's referral decision in a real-world primary care setting, with the additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram. Providers will receive access to the EMAS screening tool, called the SENSORA™ Disease Detection Platform, which features the FDA cleared 3M™ Littmann® CORE stethoscope paired with the FDA cleared SENSORA™ enterprise application and EMAS AI running on an iPad, which is mounted on a Tryten stand. SENSORA™ will be used by medical assistants or equivalent as part of the initial patient intake process (e.g., during vitals acquisition).

EMAS influence on individual providers will be assessed by reviewing each provider's number of referrals to cardiology and number of echocardiogram orders for the 6 months preceding study start. These values will be compared to cardiac referral and order rates at the end of the study. Patient outcomes data (e.g., cardiology appointment notes, echocardiogram findings, follow up visits scheduled) will be pulled 6 months after the patient is seen by their primary care provider. Secondary objectives include the continued assessment of algorithm performance on a point-of-care population.

Eligibility criteria: Inclusion Criteria:

* Patient verbally consents to participation
* Patient is willing to have heart sounds recorded with an electronic stethoscope
* Patient is age 50 years or older

Exclusion Criteria:

* Patient is unwilling or unable to give verbal informed consent
* Patients experiencing a known or suspected acute cardiac event
* Patient is under the age of 50 years old

Primary outcomes:
measure: Impact of EMAS on echocardiogram order rates
timeFrame: 01/17/2022 - 11/30/2023
measure: Impact of EMAS on cardiologist consult order rates
timeFrame: 01/17/2022 - 11/30/2023
measure: Impact of EMAS on provider decision-making
timeFrame: 01/17/2022 - 11/30/2023
Secondary outcomes:
measure: Impact of EMAS on patient outcomes
timeFrame: 01/17/2022 - 11/30/2023
measure: Sensitivity and specificity
timeFrame: 01/17/2022 - 11/30/2023
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References: