Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China

March 19, 2025 updated by: Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
This project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for children with congenital heart disease in China, establish a platform and mechanism for the collection and sharing of data on children with congenital heart disease in China, and create a real-world public database of children with congenital heart disease in China that benchmarks the international level, so as to provide a solid data foundation for high-quality research on children with congenital heart disease in China.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

35000

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

Study Locations

  • China
      • Jinan, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430016
        • Recruiting
        • Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Yong Zhang, MM
          • Phone Number: 13886842352
    • Qinghai
      • Xining, Qinghai, China, 810007
        • Recruiting
        • Qinghai Women & Children'S Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • Recruiting
        • Kunming Children's hospital
        • Contact:
          • Jieqing Min
          • Phone Number: 13888867101
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with congenital heart disease confirmed by cardiac ultrasound examination

Description

Inclusion Criteria:

  1. Age 0-18 years, regardless of gender;
  2. Patients diagnosed with congenital heart disease confirmed by cardiac ultrasound examination;

Exclusion Criteria:

None

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
Change of condition
Time Frame: Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery
The discharge records were extracted and written by the attending doctor, and the values were divided into cured, improved, unhealed, and died
Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Kun Sun, MD, Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, 200092, China

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)

June 1, 2019

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHEC-C-2024-159-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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