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

NCT06885307 | Recruiting DMC

• 1 other identifier: XHEC-C-2024-159-1
• Study Type: observational
• Target: 35,000
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Congenital Heart Disease (CHD)

Keywords

Congenital Heart Disease (CHD); Database

Outcome Measures

Primary Outcomes (1)

• Change of condition

  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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with congenital heart disease confirmed by cardiac ultrasound examination

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (6)

Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430016, China

RECRUITING

Qinghai Women & Children'S Hospital

Xining, Qinghai, 810007, China

RECRUITING

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Kunming Children's Hospital

Kunming, Yunnan, 650034, China

RECRUITING

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kun Sun, MD

  Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, 200092, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Sun, MD

CONTACT

8621-25076045; drsunkun@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Pediatric Cardiology

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 20, 2025
• Study Start: June 1, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-02

Locations

CN (6)