Study on AI Recognition System Of Heart Sound In Congenital Heart Disease Screening

Study Overview
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Brief Summary
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The objective of this study is to establish AI algorithm based on the deep learning to strengthen the ability to classify the heart murmurs of healthy people and different major or other subdivided congenital heart diseases(CHDs) and to evaluate the effectiveness of artificial intelligence technology-assisted heart sound recognition system (referred to as: Heart sound AI recognition system) for multi-center CHD screening.

Detailed Description
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This is a multi-center cluster cross-sectional study in CHINA. Heart sounds will be collected by auscultation using an electronic stethoscope in children (0   18 years old) confirmed with or without CHDs by echocardiography during outpatient or hospitalization in 10 pediatric medical centers. Heart sounds will be visualized as phonocardiogram, and feature extraction will be done after classification of normal and abnormal heart sounds and labeling the characteristics of heart murmurs by pediatric cardiovascular specialists. Artificial intelligence algorithm (machine learning, deep learning, etc.) will be trained to build a heart sounds recognition system with the data mentioned above.We will use the receiver operating characteristic (ROC) curve to compare the ability of recognition and classification of abnormal heart sounds between different artificial intelligence algorithm. Taken the results of echocardiography as the gold standard, we will use the evaluation indexes,such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity of CHD screening between the AI recognition system and human cardiovascular pediatricians. Our target is to use artificial intelligence technology to assist heart auscultation for CHD screening.

Official Title
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Multi-center Study on Exploration and Application of Artificial Intelligence Technology-Assisted Heart Sound Recognition System in Children's Congenital Heart Disease Screening

Conditions
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Congenital Heart Disease in Children

Intervention / Treatment
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* Diagnostic Test: Heart Auscultation and Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 0   18 years of age, regardless of gender ； Children with or without congenital heart disease confirmed by echocardiography； On the basis of informed consent，willing to cooperate with our group. Exclusion Criteria: ≥ 18 years of age; Children who can not undergo echocardiography or other related tests; Subjects who refuse to join in, or who are unwilling to cooperate with the provision of diagnostic and therapeutic data for further analysis and research.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0   18 years old children<br>Children During Outpatient or Hospitalization | Diagnostic Test: Heart Auscultation and Echocardiography<br>* Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receiver operating characteristic (ROC) of sensitivity | ROC of sensitivity in CHD screening by different artificial intelligence algorithm and auscultation | July 2020 to December 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart Disease, Artificial Intelligence, Heart Sound