Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism
Conditions
Keywords
computed tomography, chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, result, randomized controlled trial
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.
Interventions
DIAGNOSTIC_TEST3-D CT scanning
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
Sponsors
Sheng Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| Follow-up Peak O2% | 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 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 6-minutes walking distance | 6-24 months after the surgeries | Assessed by CPET |
| Follow-up tricuspid annular plane systolic excursion | 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 tricuspid insufficiency level | 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) |
Countries
China
Contacts
Primary ContactSheng Liu, MD
Backup ContactJiade Zhu, MD
Outcome results
None listed