- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600051
Automated Phonocardiography Analysis in Adults
Phonokardiographie Bei Erwachsenen
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists.
Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III).
Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist.
Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8010
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults with a heart defect verified by echocardiography
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity for pathological heart murmur detection
Time Frame: 2 months
|
Ability to detect a pathological heart murmur in digital heart sound recordings obtained from an elderly population with heart valve disease.
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rita Riedlbauer, MD, Medical University of Graz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- GRZ03 (PbE)
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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