The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from Baseline pulmonary mean pressure within 1 month
研究概览
简要总结
This study is a effectiveness study of the application of high-definition enhanced computed-tomography for patients with chronic thromboembolic pulmonary hypertension(CTEPH).The patients with CTEPH was randomized into 2 groups,precise pulmonary endarterectomy group(guided by enhanced CT scanning) and traditional pulmonary endarterectomy group,the hemodynamic changes tested with right sided heart catherization from baseline to post-operative period and end-point including peri-operative deaths,follow-up mortality,follow-up parameters of ultrasonic cardiogram(UCG),right-sided heart catherization(RHC),nuclear magnetic resonance imaging(MRI),cardiac pulmonary exercise test(CPET) are documented,so as to compare the prognosis between these 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosed with chronic thromboembolic pulmonary hypertension with the right-sided cathrization and pulmonary angiography;
- •The computed tomography imaging implied that the location of the embolism could be reached with surgeries;
排除标准
- •Beyond the age limit described above,or combined with other severe conditions such as severe organ dysfunction and considered contraindicated for surgical therapy by the cardiac surgeons;
- •Without the consent by the patient or his/her families;
- •Acute pulmonary embolism;
- •Pulmonary sarcoma;
- •Pulmonary arteritis;
- •Combined with cardiogenic pulmonary hypertension or idiopathic pulmonary hypertension;
研究组 & 干预措施
Precise
precise PEA therapy with the guide of 3-D imaging techniques
干预措施: 3-D CT scanning (Diagnostic Test)
Placebo
traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method
干预措施: 3-D CT scanning (Diagnostic Test)
结局指标
主要结局
Change from Baseline pulmonary mean pressure within 1 month
时间窗: within 1 month before and after pulmonary endarterectomy surgery
Mean pulmonary pressure result tested by right-sided heart
Change from Baseline pulmonary systolic pressure within 1 month
时间窗: within 1 month before and after pulmonary endarterectomy surgery
Systolic pulmonary pressure result tested by right-sided heart
Change from Baseline pulmonary vascular resistance within 1 month
时间窗: within 1 month before and after pulmonary endarterectomy surgery
Pulmonary vascular resistance result tested by right-sided heart
Change from Baseline cardiac output within 1 month
时间窗: within 1 month before and after pulmonary endarterectomy surgery
Cardiac output result tested by right-sided heart
mortality rate after surgery
时间窗: immediately after the surgery to the longest 48 months follow-up period
mortality rate after surgery
次要结局
- Follow-up tricuspid insufficiency level(3-24 months after the surgeries)
- Follow-up right ventricular anterior-posterior diameter(3-24 months after the surgeries)
- Follow-up right ventricular ejection fraction(3-24 months after the surgeries)
- Follow-up tricuspid annular plane systolic excursion(3-24 months after the surgeries)
- Follow-up 6-minutes walking distance(6-24 months after the surgeries)
- Follow-up peak oxygen consumption (Peak O2) result(6-24 months after the surgeries)
- follow-up NYHA classes(6-24 months after surgeries)
- Follow-up Peak O2%(6-24 months after the surgeries)
研究者
Sheng Liu
Adult Cardiac Surgery Center
Chinese Academy of Medical Sciences, Fuwai Hospital