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The differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. With the development of technology it is now possible to help diagnose heart murmurs using computer aided auscultation systems (CAA). eMurmur ID is an investigational CAA system (not FDA cleared) and the investigators hypothesize that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity not worse compared to a similar FDA cleared CAA system on market.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Heart Murmur Detection AI | Device | Automated AI algorithm-based analysis of digital heart sound recordings to detect and classify heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. AI algorithm results for each recording include: AHA classification (Class I (pathologic heart murmur) versus class III (innocent heart murmur or no heart murmur), murmur timing, murmur grade, heart rate and S1/S2 identification. |
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| Measure | Description | Time Frame |
|---|---|---|
| eMurmur ID sensitivity and specificity | The primary endpoints of the study are sensitivity and specificity. The clinical reference gold standard diagnosis is defined as expert physicians' diagnosis confirmed by independently interpreted echocardiogram diagnosis. True positive (TP), true negative (TN), false positive (FP) and false negative (FN) will be determined via comparison of the heart murmur classification results with the clinical gold standard (echocardiogram) diagnosis. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be chosen based on the heart murmur types required to meet a specified target patient population. Pre-selection of AHA class I and AHA class III patients will be done to achieve a reasonably similar distribution of murmur types compared to a US patient population. All major pathological and innocent murmur types will be included and their occurrence depending on age will be considered. Number of participants drawn: 120 participants across all ages will be included, 75% pediatric and 25% adult.
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| Name | Affiliation | Role |
|---|---|---|
| Lillian Lai, MD | Children's Hopsital of Eastern Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Eastern Ontario | Ottawa | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26990211 | Background | Lai LS, Redington AN, Reinisch AJ, Unterberger MJ, Schriefl AJ. Computerized Automatic Diagnosis of Innocent and Pathologic Murmurs in Pediatrics: A Pilot Study. Congenit Heart Dis. 2016 Sep;11(5):386-395. doi: 10.1111/chd.12328. Epub 2016 Mar 15. |
| Label | URL |
|---|---|
| Computerized Automatic Diagnosis of Innocent and Pathologic Murmurs in Pediatrics: A Pilot Study. | View source |
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| ID | Term |
|---|---|
| D006337 | Heart Murmurs |
| D006330 | Heart Defects, Congenital |
| D054160 | Systolic Murmurs |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |