Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data

Heart Diseases Clinical Trial

Official title:

Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929133
• Other study ID #: XH-16-040
• Status: Recruiting
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Zhao Pengjun, MD
• Phone: 13918109566
• Email: pjunzhao[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

• Neonatal ward patients

• Patients with echocardiography reports

Exclusion Criteria:

• Severe pneumonia

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• automatic screening machine on congenital heart disease

Locations

Country	Name	City	State
China	Zhao Pengjun	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (11)

A. G. Tilkian and M. B. Conover, Understanding Heart Sounds and Murmurs: With an Introduction to Lung Sounds.NewYork,NY, USA: ElsevierHealth Sciences, 2001.

Barry Poplaw. PORTABLE SMART STETHOSCOPE FORMED OF SMART MOBILE DEVICE AND CASING ASSEMBLY:US,US 2015/0327812 A1[P]. 2015

G. Douglas et al., Macleod's Clinical Examination. New York, NY, USA: Elsevier Health Sciences, 2009

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. — View Citation

Huang GY. Screening markers of congenital heart disease and their clinical values. Chinese Journal of Practical Pediatrics , 2013(7):503-504

KUN-HIS TSAI. METHOD, SYSTEM AND DEVICE FOR AUSCULTATION:US,US2016/0143612 A1[P]. 2016

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. Review. — View Citation

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. — View Citation

Winther S, Schmidt SE, Holm NR, Toft E, Struijk JJ, Bøtker HE, Bøttcher 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. — View Citation

Zhang HX,Cheng XF.Heart sound analysis virtual instrument based on LabVIEW platform. Computer Technology and Development,2010,11:217-220

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Predictive Value	The ratio of truly congenital heart disease cases divide by the total positive cases detected by the screening test.	2days