- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307030
Study on AI Recognition System Of Heart Sound In Congenital Heart Disease Screening
April 19, 2023 updated by: Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Multi-center Study on Exploration and Application of Artificial Intelligence Technology-Assisted Heart Sound Recognition System in Children's Congenital Heart Disease Screening
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: KUN SUN, MD
- Phone Number: 8621-25076045
- Email: drsunkun@xinhuamed.com.cn
Study Locations
-
-
-
Beijing, China
- Recruiting
- Beijing Anzhen Hospital
-
Contact:
- Wei Li
- Phone Number: 0086-13436312289
-
Chongqing, China
- Recruiting
- Children's Hospital Affiliated to Chongqing Medical University
-
Contact:
- Jia Liu
- Phone Number: 0086-13438054141
- Email: 597256423@qq.com
-
Guangxi, China
- Recruiting
- The First Affiliated Hospital of Guangxi Medical University
-
Contact:
- Suyuan Tan
- Phone Number: 0086-13768510719
-
Guangzhou, China
- Recruiting
- Guangzhou women and children's medical center
-
Contact:
- Wei Li
- Phone Number: 0086-18100202077
-
Hangzhou, China
- Recruiting
- Children's Hospital Affiliated to Zhejiang Medical University
-
Contact:
- Yujia Wang
- Phone Number: 0086-13588747101
- Email: wangyujia@zju.edu.cn
-
Hunan, China
- Recruiting
- Hunan Children's Hospital
-
Contact:
- Zhi Chen, MD
- Phone Number: 0086-13787028209
-
Jinan, China
- Recruiting
- Shandong Provincial Hospital
-
Contact:
- Jianli Lv, MD
- Phone Number: 0086-15562565679
- Email: smart.jaly@163.com
-
Kunming, China
- Recruiting
- Kunming Children's hospital
-
Contact:
- Nan Zheng
- Phone Number: 0086-17387744720
-
Lanzhou, China
- Recruiting
- Lanzhou University Second Hospital
-
Contact:
- Jin Wang
- Phone Number: 0086-13993129500
-
Linyi, China
- Recruiting
- Linyi Hospital for Women and Children
-
Contact:
- Shiqiang Wu
- Phone Number: 0539-3216251
- Email: 604287252@qq.com
-
Shanghai, China
- Recruiting
- Shanghai Children's Medical Center
-
Contact:
- Tianyi Ji, MD
- Phone Number: 0086-15317026159
- Email: 15317026159@126.com
-
Shanghai, China
- Recruiting
- Children's Hospital of Shanghai
-
Contact:
- Wei Liu
- Phone Number: 0086-17702159185
-
Shiyan, China
- Recruiting
- Shiyan Taihe Hospital
-
Contact:
- Shibing Xi
- Phone Number: 0086-13397298282
- Email: Xishibing2009@163.com
-
Suzhou, China
- Recruiting
- Children's Hospital of Soochow University
-
Contact:
- Qiuqin Xu
- Phone Number: 0086-13915538909
-
Wenzhou, China
- Recruiting
- The Second Hospital Affiliated to Wenzhou Medical University
-
Contact:
- Xing Rong, MD
- Phone Number: 0577-88002178
- Email: Rstar1978mail@163.com
-
Wuhan, China
- Recruiting
- Wuhan Children's Hospital
-
Contact:
- Jia Fu
- Phone Number: 0086-15827103182
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Pediatric population during outpatient service or hospitalization in ten pediatric medical centers in CHINA
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
0 ~ 18 years old children
Children During Outpatient or Hospitalization
|
Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receiver operating characteristic (ROC) of sensitivity
Time Frame: July 2020 to December 2021
|
ROC of sensitivity in CHD screening by different artificial intelligence algorithm and auscultation
|
July 2020 to December 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: KUN SUN, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
December 31, 2021
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
March 11, 2020
First Posted (Actual)
March 13, 2020
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-20-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Congenital Heart Disease in Children
-
Children's Mercy Hospital Kansas CityChildren's Hospital of Philadelphia; University of North Carolina, Chapel Hill and other collaboratorsRecruitingCongenital Heart Disease in ChildrenUnited States
-
HealthCore-NERIPediatric Heart NetworkRecruitingCongenital Heart Disease in ChildrenUnited States, Canada
-
University Hospital, Strasbourg, FranceRecruitingCongenital Heart Disease in ChildrenFrance
-
University Children's Hospital, ZurichCompletedCongenital Heart Disease in ChildrenSwitzerland
-
Johns Hopkins UniversityRecruitingCongenital Heart Disease in ChildrenUnited States
-
Assiut UniversityNot yet recruitingCommon Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical AuditCongenital Heart Disease in Children
-
Queen Fabiola Children's University HospitalTerminatedCongenital Heart Disease in ChildrenBelgium
-
Boston Children's HospitalThe Hospital for Sick Children; Baylor College of Medicine; Children's Hospital... and other collaboratorsRecruitingCongenital Heart Disease in ChildrenUnited States, Canada
-
University Hospital, Strasbourg, FranceCompletedCongenital Heart Disease in ChildrenFrance
-
Kosuyolu Heart HospitalKocaeli University; Sakarya University; Sabanci University; Maras Necip Fazil City... and other collaboratorsCompleted
Clinical Trials on Heart Auscultation and Echocardiography
-
National Heart Centre SingaporeUnknownHypertension | Hypertensive Heart DiseaseSingapore
-
CSD Labs GmbHCompletedSystolic Murmurs | Heart Murmurs | Mitral Valve ProlapseCanada
-
CSD Labs GmbHCompletedSystolic Murmurs | Heart Murmurs | Mitral Valve ProlapseAustria
-
Sociedad Española de Neumología y Cirugía TorácicaCompletedRespiratory Disorder | Heart DisorderSpain
-
Medical University of GrazCompletedMyelodysplastic Syndromes | Pulmonary Hypertension | Myeloproliferative DisorderAustria
-
Healthy NetworksUniversity of Manchester; Belarusian Medical Academy of Post-Graduate EducationRecruiting
-
Alejandro Rodriguez Oviedo , MDTerminatedMyocardial Ischemia | Pneumonia, PneumococcalSpain
-
Jingyi RenActive, not recruitingPulmonary Hypertension | Right Heart FailureChina
-
Aarhus University Hospital SkejbyCompletedHeart Transplant RecipientsDenmark
-
Hospices Civils de LyonRecruitingCardiomyopathies | Left Ventricular Hypertrophy | Hypertension Arterial | HypokineticFrance