Detecting pulmonary hypertension using an electronic stethoscope
Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Single-lead Electrocardiogram
This study is testing if a special electronic stethoscope can help doctors spot signs of pulmonary hypertension earlier in adults who are already being checked for this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eko Devices, Inc. Industry-sponsored |
| Locations | 3 sites (Providence, Rhode Island and 2 other locations) |
| Trial ID | NCT05873387 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether phonocardiography, utilizing the Eko DUO stethoscope that captures a three-lead ECG, can identify features indicative of pulmonary hypertension (PH) as diagnosed by echocardiography or right heart catheterization. By analyzing the sounds of the heart and lungs, the study seeks to assist healthcare providers in suspecting PH earlier and more accurately. The research focuses on patients over 18 years old who are referred for echocardiography or right heart catheterization, aiming to improve diagnostic methods for this serious condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are being referred for echocardiography or right heart catheterization.
Not a fit: Patients undergoing limited echocardiography or those who are intubated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of pulmonary hypertension, potentially improving patient outcomes.
How similar studies have performed: While the use of digital stethoscopes and deep learning in detecting cardiovascular conditions is an emerging field, this specific approach to diagnosing pulmonary hypertension is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients, ages \>18 years, referred for complete 2-dimensional echocardiography or right heart catheterization will be screened for inclusion. Exclusion Criteria: * Patients undergoing limited echocardiography * Intubated patients
Where this trial is running
Providence, Rhode Island and 2 other locations
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
- The Miriam Hospital — Providence, Rhode Island, United States (Recruiting)
- Providence VA Medical Center — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Guarav Choudhary, MD — Lifespan
- Study coordinator: Spencer Kieu
- Email: spencer.kieu@ekohealth.com
- Phone: 714-623-6652
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.