Detect reduced left ventricular ejection fraction using a three-lead ECG and heart sounds with AI
Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence
This will test whether an AI that uses a three-lead ECG and digital stethoscope heart sounds can tell if an adult has an ejection fraction ≤ 40%.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eko Devices, Inc. Industry-sponsored |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT07270692 on ClinicalTrials.gov |
What this trial studies
This observational study trains and evaluates an algorithm to predict an ejection fraction ≤ 40% using inputs from a three-lead ECG and heart sounds captured by Eko digital stethoscopes. Clinical echocardiogram results within seven days of recording serve as the reference standard for left ventricular ejection fraction. The project also examines how algorithm performance varies by age, gender, and race. Participants are adult outpatients able to give consent and undergo the required echocardiogram.
Who should consider this trial
Good fit: Adults aged 18 and older who can give informed consent and complete a clinical echocardiogram within seven days before or after the recordings are ideal candidates.
Not a fit: Hospitalized patients and those unable to provide informed consent or complete a timely echocardiogram are not eligible and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could provide a low-cost, noninvasive way to screen adults for reduced ejection fraction earlier and more broadly.
How similar studies have performed: Prior work using AI on standard 12-lead ECGs has shown promise for detecting low ejection fraction, but combining three-lead ECGs with digital stethoscope heart sounds is less tested and more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older * Able and willing to provide informed consent * Complete a clinical echocardiogram within 7 days before or after study procedures Exclusion Criteria: * Unwilling or unable to provide informed consent * Patients who are hospitalized
Where this trial is running
Mumbai, Maharashtra
- P. D. Hinduja Hospital and Medical Research Centre — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: Clinical Research Associate
- Email: jackrin.walsh@ekohealth.com
- Phone: 8443563384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.