Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting

NCT05176899 | Terminated

• 1 other identifier: 2021.12
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Murmur, Heart; Innocent Murmurs; Heart Murmurs; Pathologic Murmur

Keywords

artificial intelligence; machine learning

Outcome Measures

Primary Outcomes (3)

• Impact of EMAS on echocardiogram order rates

  Echocardiogram order rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole

  01/17/2022 - 11/30/2023

• Impact of EMAS on cardiologist consult order rates

  Cardiology consultation referral rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole

  01/17/2022 - 11/30/2023

• Impact of EMAS on provider decision-making

  Impact of EMAS on provider decision to refer to echocardiogram, cardiologist, or other workup related to cardiac murmur. Measured via a survey administered to each provider after each patient is screened, which asks if SENSORA AI influenced their decision to refer or not to refer. Measured for individual providers and aggregated for the site as a whole.

  01/17/2022 - 11/30/2023

Secondary Outcomes (2)

• Impact of EMAS on patient outcomes

  01/17/2022 - 11/30/2023

• Sensitivity and specificity

  01/17/2022 - 11/30/2023

Study Arms (2)

Prospective cohort

Patients who are at least 50 years of age during their primary care exam will undergo SENSORA™ screening if they provide consent.

Device: Use of Eko CORE electronic stethoscope

Retrospective cohort

Patients who saw participating providers in the 6 months prior to study start date, and who were referred to echocardiogram and/or cardiology, will be included as provider self-control for patient outcomes and referral rates.

Interventions

Use of Eko CORE electronic stethoscope DEVICE

Recording of heart sounds using electronic stethoscope

Prospective cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Heart Murmurs

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: March 11, 2022
• Primary Completion: August 3, 2023
• Study Completion: January 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)