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

Sheng Liu

Status: Unknown

Conditions: Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension

Treatments: Diagnostic Test: 3-D CT scanning

Study type: Interventional

Funder types: Other

Identifiers

NCT03795740

liusheng-1999

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups, including a placebo group

Precise

Experimental group

Description:

precise PEA therapy with the guide of 3-D imaging techniques

Treatment:

Diagnostic Test: 3-D CT scanning

Placebo

Placebo Comparator group

Description:

traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method

Treatment:

Diagnostic Test: 3-D CT scanning