The Accuracy of an Artificially-intelligent Stethoscope

NCT ID: NCT00564122

Last Updated: 2011-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-06-30

Brief Summary

This study will characterize the accuracy of a commercially available artificially-intelligent stethoscope in determining which childhood murmurs suggest underlying congenital structural heart disease and therefore warrant diagnostic echocardiograms.

Detailed Description

Heart murmurs can be ausculted in most pediatric patients, but underlying Congenital Structural Heart (CSH) Disease is rare. Nevertheless, CSH Disease is often first suggested by the presence of a murmur. Primary care providers refer pediatric patients to Cardiologists for murmur evaluations with low accuracy, and this pattern results in:

1. needless emotional strain on many patients with functionally normal hearts and their families,

2. increased morbidity and mortality rates for rare patients with delayed cardiac diagnoses, and

3. exorbitant costs to society.

Referral accuracy for murmur evaluations probably is low because the differences between innocent and pathological murmurs can be subtle. Computer-assisted analysis of heart sounds may increase the accuracy of primary care referrals to pediatric cardiologists, but the accuracy of the only FDA-approved artificially-intelligent cardiac auscultation system, Zargis Medical Corporation's Cardioscan®, has never been determined prospectively in an unselected population of live pediatric patients. As a primary endpoint, the study herein proposed would prospectively compare the sensitivity and specificity of the Cardioscan® with that of CHMCA's Pediatric Cardiologists in the identification of cardiac pathology among 300 new and unselected pediatric patients referred to CHMCA's cardiologists for murmur evaluations, using two-dimensional transthoracic echocardiography as the common gold-standard. Double-blinding will be in place. The study also will attempt secondarily to gauge the clinical significance of pathology missed by the Cardioscan®, to define sub-populations of patients among which the Cardioscan's® judgment should be considered less accurate, and to gather data concerning the value and acceptability to families of the Cardioscan®. If (as expected) the Cardioscan's® accuracy merely approaches that of Pediatric Cardiologists, then the study herein proposed would still establish the Cardioscan® as a formidable tool for primary care providers-a helpful, billable, and potentially cost-saving alternative to consulting Cardiology on patients with probably- or possibly-innocent murmurs. Data collection for this project will occur predominantly within CHMCA's Heart Center in Akron, although some data collection may occur within CHMCA and/or at CHMCA's Heart Centers in Beachwood and/or Boardman. Minimal disruption to existing clinical patient flow through those settings would be expected and the entire protocol is expected to be completely painless and noninvasive, with no foreseeable health risks.

Conditions

Heart Murmurs; Congenital Heart Disease; Structural Heart Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

All subjects

Artificially-Intelligent Stethoscope

Intervention Type: DEVICE

After subjects' medical visits are complete, the heart sounds of all subjects will be recorded and assessed by an artificially-intelligent stethoscope. Attempts will be made to make satisfactory 20-second recordings from a total of eight positions on the chest with the patient in supine and upright positions.

Physical Examination

Intervention Type: OTHER

A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.

Interventions

Artificially-Intelligent Stethoscope

After subjects' medical visits are complete, the heart sounds of all subjects will be recorded and assessed by an artificially-intelligent stethoscope. Attempts will be made to make satisfactory 20-second recordings from a total of eight positions on the chest with the patient in supine and upright positions.

Intervention Type: DEVICE

Physical Examination

A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.

Intervention Type: OTHER

Other Intervention Names

Cardioscan, Zargis Medical Corporation, Serial Number 000127

Eligibility Criteria

Inclusion Criteria

• The patient must present to a consulted cardiologist for a 1st non-primary care murmur evaluation.

Exclusion Criteria

• Non English-speakers
• At least moderately agitated or disruptive patients
• An echocardiogram or a Cardiology evaluation was done previously
• The patient no longer has an ausculable murmur at presentation.
• The patient didn't have a transthoracic echocardiogram with Color Doppler done.
• Patients admitted to the NICU before protocol completes.
• Protocol can't be completed on the day of presentation.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas C. Dispenza, M.D.

UNKNOWN

Sponsor Role: collaborator

John R. Bockoven, M.D. M.B.A.

UNKNOWN

Sponsor Role: collaborator

Akron Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas C. Dispenza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Akron Children's Hospital

John R. Bockoven, M.D. M.B.A.

Role: PRINCIPAL_INVESTIGATOR

Akron Children's Hospital

Locations

Akron Children's Hospital's Heart Center

Akron, Ohio, United States

Akron Children's Hospital's Heart Center

Beachwood, Ohio, United States

Akron Children's Hospital's Heart Center

Boardman, Ohio, United States

Countries

United States

Other Identifiers

070904

Identifier Type: -

Identifier Source: org_study_id