Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT
- Conditions
- Chronic Thromboembolic Pulmonary HypertensionPulmonary Embolism
- Interventions
- Diagnostic Test: 3-D CT scanning
- Registration Number
- NCT03795740
- Lead Sponsor
- Sheng Liu
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 3-D CT scanning traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method Precise 3-D CT scanning precise PEA therapy with the guide of 3-D imaging techniques
- Primary Outcome Measures
Name Time Method Change from Baseline pulmonary mean pressure within 1 month 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 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 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 within 1 month before and after pulmonary endarterectomy surgery Cardiac output result tested by right-sided heart
mortality rate after surgery immediately after the surgery to the longest 48 months follow-up period mortality rate after surgery
- Secondary Outcome Measures
Name Time Method Follow-up tricuspid insufficiency level 3-24 months after the surgeries Assessed by UCG
Follow-up right ventricular anterior-posterior diameter 3-24 months after the surgeries Assessed by UCG
Follow-up 6-minutes walking distance 6-24 months after the surgeries Assessed by CPET
Follow-up right ventricular ejection fraction 3-24 months after the surgeries Assessed by UCG
Follow-up tricuspid annular plane systolic excursion 3-24 months after the surgeries Assessed by UCG
Follow-up peak oxygen consumption (Peak O2) result 6-24 months after the surgeries Assessed by cardio-pulmonary exercise test (CPET)
follow-up NYHA classes 6-24 months after surgeries NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up
Follow-up Peak O2% 6-24 months after the surgeries Assessed by CPET
Trial Locations
- Locations (1)
Fuwai Hospital,Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China