EKO SENSORA: Detecting Clinically Significant Murmurs
Early Phase 1
Recruiting
- Conditions
- Heart Murmurs
- Interventions
- Device: Eko Sensora
- Registration Number
- NCT06155643
- Lead Sponsor
- Spectrum Health - Lakeland
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eko Device Eko Sensora Patients with cardiac risk factors
- Primary Outcome Measures
Name Time Method Number of new clinically significant heart murmurs detected through study completion, an average of 90 days
- Secondary Outcome Measures
Name Time Method Number of echocardiograms ordered through study completion, an average of 90 days
Trial Locations
- Locations (1)
Corewell Health Lakeland
🇺🇸Saint Joseph, Michigan, United States