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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 ~ 18 years old children | Children During Outpatient or Hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Auscultation and Echocardiography | Diagnostic Test | Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric population during outpatient service or hospitalization in ten pediatric medical centers in CHINA
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KUN SUN, MD | Contact | 8621-25076045 | drsunkun@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| KUN SUN, MD | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | China |
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| Children's Hospital Affiliated to Chongqing Medical University | Recruiting | Chongqing | China |
|
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Guangxi | China |
|
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | China |
|
| Children's Hospital Affiliated to Zhejiang Medical University | Recruiting | Hangzhou | China |
|
| Hunan Children's Hospital | Recruiting | Hunan | China |
|
| Shandong Provincial Hospital | Recruiting | Jinan | China |
|
| Kunming Children's Hospital | Recruiting | Kunming | China |
|
| Lanzhou University Second Hospital | Recruiting | Lanzhou | China |
|
| Linyi Hospital for Women and Children | Recruiting | Linyi | China |
|
| Children's Hospital of Shanghai | Recruiting | Shanghai | China |
|
| Shanghai Children's Medical Center | Recruiting | Shanghai | China |
|
| Shiyan Taihe Hospital | Recruiting | Shiyan | China |
|
| Children's Hospital of Soochow University | Recruiting | Suzhou | China |
|
| The Second Hospital Affiliated to Wenzhou Medical University | Recruiting | Wenzhou | China |
|
| Wuhan Children's Hospital | Recruiting | Wuhan | China |
|
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D006326 | Heart Auscultation |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001314 | Auscultation |
| D010808 | Physical Examination |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
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