What this study is
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.
What's being tested
- Eko Sensora
Intervention · DEVICE
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.
Study details
- Sponsor
- Corewell Health South
- Conditions
- Heart Murmurs
- Enrolling
- 300 people
- Starts
- 2023-10-26
- Est. completion
- 2027-07-26
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Contact isolation patients
- Pediatric patients under the age of 18
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCorewell Health Lakeland
Saint Joseph, Michigan, United States
- Amanda Borchardt, PhD · Contact2699838679amanda.borchardt@corewellhealth.org
- Matthew Hysell, MD · Contactmatthew.hysell@corewellhealth.org
Recruiting
Study team
Sponsor
Corewell Health South
Study ID 1635
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.