Heart MurmursNCT00564122
The Accuracy of an Artificially-intelligent Stethoscope
An observational study of Heart Murmurs and Congenital Heart Disease, run by Akron Children's Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Murmurs, Congenital Heart Disease, Structural Heart Disease
- What is being tested?
- Artificially-Intelligent Stethoscope and Physical Examination
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patient must present to a consulted Cardiologist for a 1st non-primary care murmur evaluation. This will usually occur in an outpatient Pediatric Cardiology clinic site.
Who may be able to join
- The patient must present to a consulted cardiologist for a 1st non-primary care murmur evaluation.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Akron Children's Hospital's Heart Center
Akron, Ohio, 44308
Akron Children's Hospital's Heart Center
Beachwood, Ohio, 44122
Akron Children's Hospital's Heart Center
Boardman, Ohio, 44512
About this study
Official title: A Comparison of the Accuracy of an Artificially-Intelligent Stethoscope Versus Pediatric Cardiologists in the Assessment of Pediatric Patients Referred to a Cardiologist for the Assessment of a Heart Murmur
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.
Read the 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:
- needless emotional strain on many patients with functionally normal hearts and their families,
- increased morbidity and mortality rates for rare patients with delayed cardiac diagnoses, and
- 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.
- Being tested
- Artificially-Intelligent Stethoscope, Physical Examination
- Keywords
- Murmur, Artificial-Intelligence, Stethoscope, Congenital Heart Disease, Structural Heart Disease
- Medical subject headings
- Heart Murmurs, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificially-Intelligent StethoscopeDevice
Also called Cardioscan, Zargis Medical Corporation, Serial Number 000127
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 ExaminationOther
A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Not described Receives: Device: Artificially-Intelligent Stethoscope; Other: Physical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease
Measured: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.
Secondary outcomes (1)
Specificity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease.
Measured: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startDec 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart MurmursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas C. Dispenza, M.D., John R. Bockoven, M.D. M.B.A.
- Responsible party
- Sponsor
- Investigators
- Thomas C. Dispenza, M.D., Principal investigator, Akron Children's HospitalJohn R. Bockoven, M.D. M.B.A., Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564122
- Sponsor's protocol ID
- 070904
- Status last verified
- Oct 2011
- First submitted
- 23 Nov 2007
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Accuracy of an Artificially-Intelligent Stethoscope Versus Pediatric Cardiologists in the Assessment of Pediatric Patients Referred to a Cardiologist for the Assessment of a Heart Murmur
- ClinicalTrials.gov ID
- NCT00564122
- Acronym / sponsor ID
- 070904
- Keywords
- Murmur, Artificial-Intelligence, Stethoscope, Congenital Heart Disease, Structural Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Collaborators
- Thomas C. Dispenza, M.D., John R. Bockoven, M.D. M.B.A.
- Study start
- Dec 2007
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- needless emotional strain on many patients with functionally normal hearts and their families,
- increased morbidity and mortality rates for rare patients with delayed cardiac diagnoses, and
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: Artificially-Intelligent Stethoscope, Other: Physical Examination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient must present to a consulted Cardiologist for a 1st non-primary care murmur evaluation. This will usually occur in an outpatient Pediatric Cardiology clinic site.
Key inclusion criteria (1 listed)
- The patient must present to a consulted cardiologist for a 1st non-primary care murmur evaluation.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificially-Intelligent StethoscopeAlso: Cardioscan, Zargis Medical Corporation, Serial Number 000127After 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. | Device | All subjects |
| Physical ExaminationA Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care. | Other | All subjects |
Primary outcome
Sensitivity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease
Time frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.
1 secondary outcome
Specificity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease.
Time frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
Related trials for Heart Murmurs
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
RecruitingObservational study
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Atrial Fibrillation
Recruiting
EKO SENSORA: Detecting Clinically Significant Murmurs
Heart Murmurs
Enrolling by invitationObservational study
Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds
Congenital Heart Disease (CHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C. Dispenza, M.D. principal investigator
Akron Children's Hospital
John R. Bockoven, M.D. M.B.A. principal investigator
Akron Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Murmurs and Congenital Heart Disease, run by Akron Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease (time frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.