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NCT Number: NCT06611787

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing AnZhen Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

JiaChen Li, MD

CONTACT

[email protected]

18513494314 ext. +86

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with various congenital heart diseases

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. The mortality of the first week after surgery

    Time frame: Duration of hospital stay (an expected average of 1 week)

    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

Secondary outcomes

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

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

  2. The ratio of intraoperative surgeries among all neonatal surgeries;

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

JiaChen Li, MD

CONTACT

[email protected]

18513494314 ext. +86

Qiang Wang, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

A Comprehensive Registry Study of the Whole Life Cycle of Patients With Congenital Heart Diseases

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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