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

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ClinicalTrials.gov Identifier: NCT03795740
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng Liu, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Pulmonary Embolism Diagnostic Test: 3-D CT scanning Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Precise
precise PEA therapy with the guide of 3-D imaging techniques
 Diagnostic Test: 3-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
Placebo Comparator: Placebo
traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method
 Diagnostic Test: 3-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


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline pulmonary systolic pressure within 1 month [ Time Frame: within 1 month before and after pulmonary endarterectomy surgery ]
    Systolic pulmonary pressure result tested by right-sided heart

  2. Change from Baseline pulmonary mean pressure within 1 month [ Time Frame: within 1 month before and after pulmonary endarterectomy surgery ]
    Mean pulmonary pressure result tested by right-sided heart

  3. Change from Baseline pulmonary vascular resistance within 1 month [ Time Frame: within 1 month before and after pulmonary endarterectomy surgery ]
    Pulmonary vascular resistance result tested by right-sided heart

  4. Change from Baseline cardiac output within 1 month [ Time Frame: within 1 month before and after pulmonary endarterectomy surgery ]
    Cardiac output result tested by right-sided heart

  5. mortality rate after surgery [ Time Frame: immediately after the surgery to the longest 48 months follow-up period ]
    mortality rate after surgery


Secondary Outcome Measures :
  1. Follow-up right ventricular ejection fraction [ Time Frame: 3-24 months after the surgeries ]
    Assessed by UCG

  2. Follow-up tricuspid annular plane systolic excursion [ Time Frame: 3-24 months after the surgeries ]
    Assessed by UCG

  3. Follow-up right ventricular anterior-posterior diameter [ Time Frame: 3-24 months after the surgeries ]
    Assessed by UCG

  4. Follow-up tricuspid insufficiency level [ Time Frame: 3-24 months after the surgeries ]
    Assessed by UCG

  5. Follow-up peak oxygen consumption (Peak O2) result [ Time Frame: 6-24 months after the surgeries ]
    Assessed by cardio-pulmonary exercise test (CPET)

  6. Follow-up Peak O2% [ Time Frame: 6-24 months after the surgeries ]
    Assessed by CPET

  7. Follow-up 6-minutes walking distance [ Time Frame: 6-24 months after the surgeries ]
    Assessed by CPET

  8. follow-up NYHA classes [ Time Frame: 6-24 months after surgeries ]
    NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up


Eligibility Criteria
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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795740


Contacts
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Contact: Sheng Liu, MD 13501331366 liusheng@fuwai.com
Contact: Jiade Zhu, MD 86-15801204824 15801204824@163.com

Locations
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China, Beijing
Fuwai Hospital,Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100044
Contact: Sheng Liu, MD    86-13501331366    liusheng@fuwai.com   
Sponsors and Collaborators
Sheng Liu
  Study Documents (Full-Text)

Documents provided by Sheng Liu, Chinese Academy of Medical Sciences, Fuwai Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] December 19, 2018
Informed Consent Form  [PDF] December 19, 2018

More Information
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Additional Information:

Publications:

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Responsible Party: Sheng Liu, Adult Cardiac Surgery Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03795740    
Other Study ID Numbers: liusheng-1999
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have yet no plan to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheng Liu, Chinese Academy of Medical Sciences, Fuwai Hospital:
computed tomography
chronic thromboembolic pulmonary hypertension
pulmonary endarterectomy
result
randomized controlled trial
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Embolism
Hypertension
Embolism
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis