A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease

Официальное название

Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database

Обзор

The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and create a China-specific quality control system to improve CCHD surgical care. The main questions it aims to answer are: What are the main risk factors that affect how well people with CCHD recover after heart surgery? Can a whole life course, multi-dimensional data platform for CCHD care be built to support better clinical quality control? Can a China-specific system to evaluate and control the quality of CCHD heart surgery be developed to guide national health policies and improve patient outcomes? Participants in this study are people with CCHD who have had or will have heart surgery at participating medical centers. This includes two groups: A retrospective group: People who already had CCHD heart surgery and were included in the existing National Congenital Heart Disease Surgery Database. A prospective group: People who are scheduled to have CCHD heart surgery as part of related sub-studies of this project. People who are lost to follow-up or have more than 30% missing data will not be included. Participants will: For the retrospective group: Have their past medical records (from surgery and follow-up) analyzed by researchers to find risk factors linked to recovery after CCHD heart surgery. For the prospective group: Have their pre-surgery tests, surgery details, care during and after surgery, and follow-up data (including up to 1 year after surgery) collected as part of their regular medical care. Researchers will combine data from both groups into a new registry, work with a third-party committee to check data quality, and use this combined data to build a quality control and evaluation system for CCHD heart surgery. This system will help show the current state of CCHD care in China and guide national health decisions.

Первичные конечные точки

• Identification of key risk factors for CCHD post-surgical recovery [Срок оценки: Retrospective data from baseline pre-surgery to hospital discharge post-surgery at Day 7]
• Development of a China-specific CCHD surgical quality control system [Срок оценки: From baseline (pre-surgery) until 1 year post-surgery for each enrolled participant, assessed over the entire study period of up to 48 months from study initiation]

Критерии участия

Критерии включения

• Clinical diagnosis of Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the 13th Five-Year Plan National Congenital Heart Disease Surgery Database
• Clinical diagnosis of CCHD requiring surgical/intrauterine intervention or cardiac rehabilitation
• Willing to sign informed consent and complete follow-up

Критерии исключения

• Lost to follow-up
• >30% missing core clinical data
• Severe extracardiac malformations, systemic dysfunction, or other conditions precluding study participation, per sub-study specific exclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of Medical Science, PUMC — Пекин

Идентификаторы

NCT: NCT07524998 · 2024ZD0527001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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