Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT

Study Overview
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Brief Summary
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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.

Official Title
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The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography

Conditions
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Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism

Intervention / Treatment
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* Diagnostic Test: 3-D CT scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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;

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precise<br>precise PEA therapy with the guide of 3-D imaging techniques | Diagnostic Test: 3-D CT scanning<br>* For patients in Group 1,precisely analyzed CT scanning and/or pulmonary angiography will be done,and the patients in Group 1 will receive PEA procedure with the guide of precise 3-D imaging techniques<br>|
| Placebo Comparator: Placebo<br>traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method | Diagnostic Test: 3-D CT scanning<br>* For patients in Group 1,precisely analyzed CT scanning and/or pulmonary angiography will be done,and the patients in Group 1 will receive PEA procedure with the guide of precise 3-D imaging techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline pulmonary systolic pressure within 1 month | Systolic pulmonary pressure result tested by right-sided heart | within 1 month before and after pulmonary endarterectomy surgery | 
| Change from Baseline pulmonary mean pressure within 1 month | Mean pulmonary pressure result tested by right-sided heart | within 1 month before and after pulmonary endarterectomy surgery | 
| Change from Baseline pulmonary vascular resistance within 1 month | Pulmonary vascular resistance result tested by right-sided heart | within 1 month before and after pulmonary endarterectomy surgery | 
| Change from Baseline cardiac output within 1 month | Cardiac output result tested by right-sided heart | within 1 month before and after pulmonary endarterectomy surgery | 
| mortality rate after surgery | mortality rate after surgery | immediately after the surgery to the longest 48 months follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up right ventricular ejection fraction | Assessed by UCG | 3-24 months after the surgeries | 
| Follow-up tricuspid annular plane systolic excursion | Assessed by UCG | 3-24 months after the surgeries | 
| Follow-up right ventricular anterior-posterior diameter | Assessed by UCG | 3-24 months after the surgeries | 
| Follow-up tricuspid insufficiency level | Assessed by UCG | 3-24 months after the surgeries | 
| Follow-up peak oxygen consumption (Peak O2) result | Assessed by cardio-pulmonary exercise test (CPET) | 6-24 months after the surgeries | 
| Follow-up Peak O2% | Assessed by CPET | 6-24 months after the surgeries | 
| Follow-up 6-minutes walking distance | Assessed by CPET | 6-24 months after the surgeries | 
| follow-up NYHA classes | NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up | 6-24 months after surgeries | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computed tomography, chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, result, randomized controlled trial