- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929133
Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data
April 24, 2019 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
This study intends to establish an automatic system for screening on children with congenital heart disease, the system include the auscultation of cardiac murmur and the test of oxygen saturation, the data was analyzed based on the cloud computing.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study intends to establish a system for screening of children with congenital heart disease,with the combination of cardiac auscultation , the test of oxygen saturation, the use of cloud computing and data base.
The investigators decide to do this project from three main points.1:How
to establish a data-base system?
2:How to get heart sound signal?
3.How to analyze so many signals?
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200082
- Recruiting
- Zhao Pengjun
-
Contact:
- Zhao Pengjun, MD
- Phone Number: 13918109566
- Email: pjunzhao@sina.com
-
-
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 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study include between between newborn to 10 years old.Heart sound signal need to be collected to analyze children's heart health status and creat a special model of each kind of CHD.
Description
Inclusion Criteria:
- Neonatal ward patients
- Patients with echocardiography reports
Exclusion Criteria:
- Severe pneumonia
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Predictive Value
Time Frame: 2days
|
The ratio of truly congenital heart disease cases divide by the total positive cases detected by the screening test.
|
2days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Zhao Pengjun, MD, Pediatric cardiovascular department, Shanghai xinhua hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.
- Zhao QM, Ma XJ, Ge XL, Liu F, Yan WL, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Jia B, Huang GY; Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54. doi: 10.1016/S0140-6736(14)60198-7. Epub 2014 Apr 22. Erratum In: Lancet. 2014 Aug 30;384(9945):746.
- Ho TC, Ouyang H, Lu Y, Young AH, Chintala K, Detrano RC. Postprocedural outcomes of rural children undergoing correction of congenital heart lesions in Yunnan Province, China. Pediatr Cardiol. 2011 Aug;32(6):811-4. doi: 10.1007/s00246-011-9991-y. Epub 2011 Apr 11.
- G. Douglas et al., Macleod's Clinical Examination. New York, NY, USA: Elsevier Health Sciences, 2009
- A. G. Tilkian and M. B. Conover, Understanding Heart Sounds and Murmurs: With an Introduction to Lung Sounds.NewYork,NY, USA: ElsevierHealth Sciences, 2001.
- KUN-HIS TSAI. METHOD, SYSTEM AND DEVICE FOR AUSCULTATION:US,US2016/0143612 A1[P]. 2016
- Barry Poplaw. PORTABLE SMART STETHOSCOPE FORMED OF SMART MOBILE DEVICE AND CASING ASSEMBLY:US,US 2015/0327812 A1[P]. 2015
- Winther S, Schmidt SE, Holm NR, Toft E, Struijk JJ, Botker HE, Bottcher M. Diagnosing coronary artery disease by sound analysis from coronary stenosis induced turbulent blood flow: diagnostic performance in patients with stable angina pectoris. Int J Cardiovasc Imaging. 2016 Feb;32(2):235-245. doi: 10.1007/s10554-015-0753-4. Epub 2015 Sep 3.
- Visagie C, Scheffer C, Lubbe WW, Doubell AF. Autonomous detection of heart sound abnormalities using an auscultation jacket. Australas Phys Eng Sci Med. 2009 Dec;32(4):240-50. doi: 10.1007/BF03179245.
- Huang GY. Screening markers of congenital heart disease and their clinical values. Chinese Journal of Practical Pediatrics , 2013(7):503-504
- Zhang HX,Cheng XF.Heart sound analysis virtual instrument based on LabVIEW platform. Computer Technology and Development,2010,11:217-220
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
January 1, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 22, 2016
First Submitted That Met QC Criteria
April 24, 2019
First Posted (Actual)
April 26, 2019
Study Record Updates
Last Update Posted (Actual)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-16-040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigator do not plan to share the data until the project is totally completed
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 Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Nantes University HospitalDirectorate of Health Care SupplyRecruitingHeart Diseases | Heart Failure | Heart Valve DiseasesFrance
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
National Defense Medical Center, TaiwanRecruiting
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
Shanghai Zhongshan HospitalCompletedElectrocardiogram, Valvular Heart DiseaseChina, United Kingdom
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Maria Cecilia HospitalRecruiting
-
Toho UniversityRecruiting
Clinical Trials on automatic screening machine on congenital heart disease
-
Beijing Anzhen HospitalNot yet recruitingFetal Echocardiography | Congenital Heart Disease in Pregnancy | Prenatal Diagnosis
-
Nanjing Medical UniversityUnknownCongenital Heart DiseaseChina
-
Instituto de Cardiologia do Rio Grande do SulCompletedCongenital Heart DiseaseBrazil
-
University of ArizonaCompletedCongenital DiseaseUnited States
-
Samsung Medical CenterCompletedPatients Who Underwent Surgery for Congenital Heart DiseaseKorea, Republic of
-
Samsung Medical CenterCompletedPediatric Patients | Surgery for Congenital Heart DiseaseKorea, Republic of
-
Karamanoğlu Mehmetbey UniversityCompletedPhysician's RoleTurkey (Türkiye)
-
Brugmann University HospitalNot yet recruitingCardiac Surgery | Congenital Heart Disease | Blood Transfusion | Morbidity, MultipleBelgium
-
Yeditepe UniversityNot yet recruitingCongenital Heart DiseaseTurkey
-
Radboud University Medical CenterIpsenUnknownLiver Diseases | Hepatomegaly | Polycystic Liver Disease | Polycystic Kidney | Autosomal DominantNetherlands, Belgium