New International CTEPH Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,019
- 试验地点
- 38
- 主要终点
- Lung transplantation
研究概览
简要总结
The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival.
The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (incident patients)
- •Patients must have been treated with anti-coagulation for at least 3 months before diagnosis of CTEPH
- •Patients must be willing to provide informed consent
- •Patients must meet the following criteria for CTEPH:
- •Mean pulmonary artery pressure (PAP) ≥ 25 mmHg at rest
- •Abnormal VQ scan, pulmonary angiogram, computed tomography (CT) pulmonary angiogram, or magnetic resonance (MR) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
排除标准
- •None specified
结局指标
主要结局
Lung transplantation
时间窗: Min. 3 years
Change in New York Heart Association (NYHA) functional class
时间窗: Min 3. years
Death
时间窗: Min. 3 years
次要结局
- Medical treatment(Min. 3 years)
- Pulmonary endarterectomy (PEA)(Min. 3 years)
- Balloon pulmonary angioplasty (BPA)(Min. 3 years)
- History of deep vein thrombosis (DVT)(Min. 3 years)
- Age at diagnosis(Min. 3 years)
- Patient on oxygen (yes/no)(Min. 3 years)
- Gender(Min. 3 years)
- Ethnicity(Min. 3 years)
- Disease severity(Min. 3 years)
- History of acute pulmonary embolism(Min. 3 years)
- Hemodynamic parameters(Min. 3 years)