China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-A Quality Control on Right Heart Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 3-month all cause death
研究概览
简要总结
Right heart catheterization(RHC) plays a crucial role in the diagnosis and treatment of pulmonary vascular diseases(PVD). In China, the lack of equipment and technical expertise has historically limited the implementation of RHC, thereby greatly restricting the diagnosis and treatment of RVD. In recent years, with improvements in these issues, more hospitals have acquired the capability to perform RHC. The purpose of this study is to conduct quality control of RHC across multiple pulmonary hypertension(PH) centers in China. The study population consists of patients who underwent RHC for the first time due to dyspnea or suspected PH. This study retrospectively and prospectively collects multicenter RHC data, with the main quality control contents including indications for the procedure, collection and analysis of hemodynamic data, diagnosis and treatment, and long-term management of patients.
详细描述
This study is led by the China-Japan Friendship Hospital and will be conducted across approximately 30 pulmonary hypertension centers in China. It is an observational cohort study without interventional treatment. Eligible participants are patients aged 14 years or older who undergo right heart catheterization due to dyspnea or suspected pulmonary hypertension. After study initiation, investigators at each center will enroll eligible patients and collect baseline data, hemodynamic parameters from right heart catheterization, diagnostic classification of pulmonary hypertension, and treatment plans. Patients will receive routine follow-up at their respective centers, and investigators will gather follow-up data according to the study protocol. All de-identified data will be recorded in an Electronic Data Capture (EDC) system. A dedicated data management team will oversee data management, quality control, and statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent right heart catheterization for the first time due to dyspnea or suspected pulmonary hypertension
- •Age ≥14 years old
排除标准
- •Vital data missing
- •Did not sign informed consent or did not agree to follow-up
结局指标
主要结局
3-month all cause death
时间窗: 3 month
3-month all cause death
次要结局
- dignosis and type of pulmonary hypertension(1 month)
- 1-year all cause death(1 year)
研究者
Zhenguo Zhai,MD,PhD
Professor
China-Japan Friendship Hospital