A Comprehensive Registry Study of the Whole Life Cycle of Patients With CHD

NCT06611787 | Recruiting

• 1 other identifier: AZ 2024 No. (1) RSTE
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to collect data on the prevalence, intervention, and prognosis of congenital heart disease (CHD) in Chinese patients across their entire lifecycle. From the diagnosis of CHD in fetuses, to early treatment of severe CHD in neonates, to standardized perinatal diagnosis and treatment of CHD patients with concurrent pregnancy, the study employs a cyclical model consisting of evaluation, training, improvement, and re-evaluation. The goal is to enhance the diagnostic and treatment capabilities of participating hospitals, especially for complex CHD cases, and promote standardized clinical practices in cardiovascular disease treatment among these hospitals. This will ultimately improve the quality of medical services provided to cardiovascular patients and serve as a basis for exploring CHD treatment guidelines suitable for China. The project will be implemented by Capital Medical University Affiliated Beijing Anzhen Hospital and the National Clinical Research Center for Cardiovascular Diseases. The plan is to involve more than 20 hospitals over the next five years. An independent website will be created for data collection, education and training, as well as experience sharing among participating hospitals. Starting from January 1, 2024, each hospital will continuously collect CHD inpatient cases on a monthly basis. The project team will regularly analyze and report on the completion of key medical quality evaluation indicators for each hospital. They will provide guidance measures such as education, training, experience sharing, and on-site investigations to address identified issues, helping hospitals improve medical quality. Hospitals that demonstrate excellence and significant improvement will be recognized and commended, driving overall improvement in the quality of cardiovascular medical care in China.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• The mortality of the first week after surgery

  Intraoperative surgeries encompass a broad range of procedures performed during a surgical operation, often involving complex and high-risk interventions. In terms of in-hospital mortality within 1 weeks after surgery, the risk associated with intraoperative surgeries can be elevated due to factors, the complexity of the procedure, and potential complications. Routine neonatal surgeries, on the other hand, are procedures commonly performed on newborns, often to address congenital anomalies or other medical conditions present at birth. While these surgeries are generally considered safer than more complex intraoperative procedures, there is still a risk of in-hospital mortality within 1 week after surgery, particularly for neonates with pre-existing health issues or complications during the surgical process. Close monitoring and prompt intervention are crucial to minimize this risk and ensure the best possible outcomes for neonatal patients

  Duration of hospital stay (an expected average of 1 week)

Secondary Outcomes (3)

• The ratio of newborns receiving integrated prenatal and postnatal diagnosis and treatment;

  Duration of hospital stay (an expected average of 1 week) and 5 years after discharge

• The ratio of intraoperative surgeries among all neonatal surgeries;

  Duration of hospital stay (an expected average of 1 week) and 5 years after discharge

• The rate of Medium- and long-term survival rates, and re-operations

  Duration of hospital stay (an expected average of 1 week) and 5 years after discharge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with various congenital heart diseases.

You may qualify if:

• Patients with various congenital heart diseases

You may not qualify if:

• None

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing AnZhen Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Discarded myocardial samples removed during surgery, and blood samples

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Central Study Contacts

JiaChen Li, MD

CONTACT

18513494314; lijiachen0915@126.com

Qiang Wang, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 25, 2024
• Study Start: February 2, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 25, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)