NCT05459545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

July 13, 2022

Last Update Submit

November 21, 2024

Conditions

Murmur, HeartInnocent MurmursHeart MurmursPathologic MurmurAtrial Fibrillation

Keywords

artificial intelligencemachine learning

Outcome Measures

Primary Outcomes (4)

  • Sensitivity and Specificity of Eko's AI relative to ground truth

    Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.

    02/20/2022 - 05/20/2024

  • Sensitivity and Specificity of Eko's AI relative to PCP auscultation and ground truth

    Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth and PCP auscultation ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.

    02/20/2022 - 05/20/2024

  • Positive and negative predictive values for AI detecting new VHD

    Positive and negative predictive values of Eko's algorithms for detecting new clinically significant valvular heart disease

    02/20/2022 - 05/20/2024

  • Positive and negative predictive values for PCP detecting new VHD

    Positive and negative predictive values of a PCP's outpatient visit for detecting new clinically significant valvular heart disease

    02/20/2022 - 05/20/2024

Secondary Outcomes (3)

  • Sensitivity and Specificity of Eko's AI relative to echocardiographic ground truth.

    02/20/2022 - 05/20/2024

  • Performance of the machine algorithm vs. the physician

    02/20/2022 - 05/20/2024

  • Number of cardiac tests and consultations ordered

    02/20/2022 - 05/20/2024

Interventions

Use of Eko CORE and Eko CORE 500 electronic stethoscopeDEVICE

Auscultation of heart sounds using electronic stethoscopes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pentucket Medical Associates

Haverhill, Massachusetts, 01830, United States

Location

Pentucket Medical Associates

Lawrence, Massachusetts, 01843, United States

Location

Maria Medical Center

Dunn, North Carolina, 27546, United States

Location

Edgewater Medical Center

Lillington, North Carolina, 27546, United States

Location

Hometown Medical PLLC

Lillington, North Carolina, 27546, United States

Location

MeSH Terms

Conditions

Heart MurmursAtrial Fibrillation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Design

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

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 15, 2022

Study Start

April 15, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

All participant data will be de-identified. Data will only be shared with Eko Devices, and not shared with any other researchers.

Locations

US(5)