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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06155643
Other study ID # 1635
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 26, 2023
Est. completion date May 30, 2024

Study information

Verified date May 2024
Source Spectrum Health - Lakeland
Contact Monique Luna, MS
Phone 2699838679
Email monique.allen@corewellhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023). The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction. The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope. - Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography Exclusion Criteria: - Contact isolation patients - Pediatric patients under the age of 18

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Eko Sensora
The exam involves placing the stethoscope in the aortic, pulmonic, tricuspid, and mitral areas for 15-30 seconds until a green light is displayed indicating that useful sound has been recorded. The recording is then uploaded by the device using wi-fi to the AI program for analysis. It does not carry patient identifiers. The device then indicates whether a clinically significant heart murmur was heard, and if so in which recording.

Locations

Country Name City State
United States Corewell Health Lakeland Saint Joseph Michigan

Sponsors (1)

Lead Sponsor Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of new clinically significant heart murmurs detected through study completion, an average of 90 days
Secondary Number of echocardiograms ordered through study completion, an average of 90 days
See also
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Completed NCT02512341 - Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics
Not yet recruiting NCT04306991 - Modifications of Heart Murmurs and Cardiac Output During Fever N/A
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Completed NCT04400513 - Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
Completed NCT03227848 - eMurmur ID - Clinical Performance Evaluation
Completed NCT03501836 - Wireless Handheld 8-lead ECG Device Performance in Heart Patients (Rapid Rhythm) N/A
Completed NCT03458806 - Phono- and Electrocardiogram Assisted Detection of Valvular Disease
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Enrolling by invitation NCT06070298 - Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds
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Recruiting NCT05459545 - Real-World Evaluation of Eko Algorithms in a Point of Care Setting