Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Identification of key risk factors for CCHD post-surgical recovery
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Retrospective cohort
This cohort includes 2,494 patients with Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the National Congenital Heart Disease Surgery Database. Researchers will use multivariable regression models to identify key risk factors affecting post-surgical recovery outcomes, and optimize perioperative data collection for CCHD care based on these findings.
Prospective cohort
This cohort includes 1,940 patients with Complex Congenital Heart Disease (CCHD) scheduled for surgical intervention from related sub-studies of this project. Researchers will collect comprehensive, multi-dimensional data across the entire care continuum, including preoperative evaluations, surgical procedures, perioperative management, and 1-year follow-up outcomes, as well as extend data collection to fetal and adult CCHD populations. This registry platform will support related sub-studies and contribute to the development of a nationwide multi-center CCHD cohort and China-specific surgical quality control system.
结局指标
主要结局
Identification of key risk factors for CCHD post-surgical recovery
时间窗: Retrospective data from baseline pre-surgery to hospital discharge post-surgery at Day 7
To identify and validate 5 key risk factors linked to perioperative adverse events and post-surgical recovery in patients with Complex Congenital Heart Disease (CCHD) using retrospective cohort data.
Development of a China-specific CCHD surgical quality control system
时间窗: 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
To establish a China-specific quality control and evaluation system for CCHD surgical care, which will reflect variations in CCHD care across disease subtypes, age groups, and regions, and guide improvements in clinical outcomes, medical resource use, and patient quality of life.
次要结局
未报告次要终点
研究者
Shoujun Li
Chief Physician, Professor
China National Center for Cardiovascular Diseases