Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope

July 18, 2023 updated by: Eko Devices, Inc.

Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Single-lead Electrocardiogram

The major goal of the study is to determine whether phonocardiography (using the Eko DUO stethoscope which can capture a three lead ECG reading) can present features that relate to the presence of PH diagnosed by echocardiography or right heart catheterization (RHC), and therefore have a potential to assist the provider to suspect PH.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

2420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02903
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • The Miriam Hospital
        • Contact:
        • Principal Investigator:
          • Guarav Choudhary, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients will be enrolled from Miriam and Rhode Island Hospital and Cardiovascular Institute outpatient locations where echocardiography or right heart catheterizations are performed. Approximately 40% of the patients enrolled will have a confirmed diagnosis of pulmonary hypertension.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guarav Choudhary, MD, Lifespan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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