- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873387
Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope
Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Single-lead Electrocardiogram
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pulmonary hypertension (PH) is a syndrome resulting from restricted flow through the pulmonary circulation causing increased pulmonary vascular resistance and ultimately right heart failure. There are several different subtypes of PH, however, all carry a poor prognosis and often result in or hasten death. Multiple pathogenic pathways have been implicated in the development of PH, including those at the molecular and genetic levels and in the smooth muscle and endothelial cells and adventitia.
Patients with PH are classified into five groups based on the etiology and mechanism of the disease group.1 Group 1, also called pulmonary arterial hypertension (PAH), is associated with several other systemic diseases (e.g., connective tissue disease), genetic syndromes, or drugs. Whereas, group 2 is associated with left-sided heart disease. Group 3 is due to chronic lung disorders and hypoxemia. Group 4 is due to pulmonary artery obstructions and is the subtype found in patients with chronic thromboembolic pulmonary hypertension. Lastly, Group 5 is idiopathic PH or PH with unidentified mechanism.
PH is a major pathophysiological disorder that can involve multiple clinical conditions and can complicate most cardiovascular and respiratory diseases. PH is defined as an increase in mean pulmonary artery pressure (mPAP) >20 mm Hg at rest, as assessed by right heart catheterization. Due to the invasive nature of right heart catheterization, echocardiography is an established non-invasive alternative diagnostic tool.
About 80% of all right heart catheterizations have evidence of elevated PA pressures (mPAP> 19 mm HG) and ~60% have a mean PA pressure > 25 mm Hg. Also, the prevalence of elevated PA pressure is ~ 50% on clinically indicated echocardiograms.5 Elevated PA pressure either by echocardiography or right heart catheterization is associated with increased mortality, hospitalizations and heart failure admissions.
However, since PH requires either echocardiogram or invasive catheterization, it remains underdiagnosed. Identification of a minimally invasive and rapid screening process for PH will help identify this at risk group in a primary care setting to target for further evaluation and aggressive risk factor modification. We hypothesize that combining phonocardiography (PCG) from heart auscultation with electrocardiography (ECG) may provide specific elements that correlate with PA pressures on echocardiogram and can help screen for the probability of pulmonary hypertension in a patient.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Spencer Kieu
- Phone Number: 714-623-6652
- Email: spencer.kieu@ekohealth.com
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
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Contact:
- Kelly Franchetti
- Email: kfranchetti@lifespan.org
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Providence, Rhode Island, United States, 02906
- Recruiting
- The Miriam Hospital
-
Contact:
- Lori-Ann DeSimone
- Email: ldesimone@lifespan.org
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Principal Investigator:
- Guarav Choudhary, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Echocardiography ground-truth
Subjects with ECG/PCG recordings labeled against echocardiography
|
Auscultation of heart sounds using electronic stethoscope
|
Right heart catheterization ground-truth
Subjects with ECG/PCG recordings labeled against right heart catheterization
|
Auscultation of heart sounds using electronic stethoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms
Time Frame: Up to 2 years to complete database
|
Create a training/validation dataset composed of ECG/PCG recordings by enrolling at least 2200 subjects undergoing echocardiography and at least 220 subjects who have undergone right heart catheterization (RHC)
|
Up to 2 years to complete database
|
Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity
Time Frame: Up to 3 years to complete algorithm development
|
Deliver an algorithm that detects PH with a sensitivity and specificity of ≥ 0.7
|
Up to 3 years to complete algorithm development
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guarav Choudhary, MD, Lifespan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023.3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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