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Heart DiseasesNCT03929133

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

An observational study of Heart Diseases, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 10 yearsHealthy volunteers can take part
Conditions the study is for
Heart Diseases
What is being tested?
automatic screening machine on congenital heart disease
Type of treatment
Medical device
How many people
1,000 participants
Where
1 siteChina
Study dates
Jan 2017to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • Neonatal ward patients
  • Patients with echocardiography reports

Who cannot join

  • Severe pneumonia

Trial locations and contacts

1 site in 1 country.

Zhao Pengjun, MD contact

13918109566 ext. 02125078485

pjunzhao@sina.com

China1 site, 1 recruiting

  • Zhao Pengjun

    Shanghai, Shanghai Municipality, 200082

    Zhao Pengjun, MD, 13918109566, pjunzhao@sina.com

    Recruiting

Other trials in China

About this study

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.

Read the 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?

Conditions
Heart Diseases
Being tested
automatic screening machine on congenital heart disease
Keywords
fetal heart sounds, big data, cloud computing, congenital heart disease, data base, Acoustic structure design
Medical subject headings
Heart Diseases, Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • automatic screening machine on congenital heart diseaseDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive Predictive Value

    The ratio of truly congenital heart disease cases divide by the total positive cases detected by the screening test.

    Measured: 2days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2019
  2. Study startJan 2017
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03929133
Sponsor's protocol ID
XH-16-040
Status last verified
Dec 2018
First submitted
22 Nov 2016
Last updated
26 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No: The investigator do not plan to share the data until the project is totally completed

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.

    PubMed 22078432

  • 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.

    PubMed 21479905

  • 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.

    PubMed 24768155

  • 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.

    PubMed 26335368

  • 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.

    PubMed 20169844

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Diseases, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhao Pengjun, MD (13918109566 ext. 02125078485, pjunzhao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Predictive Value (time frame: 2days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03929133, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.

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