Back to resultsPulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT (PEACT)
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3-D CT scanning
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring computed tomography, chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, result, randomized controlled trial
Eligibility 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;
Sites / Locations
- Fuwai Hospital,Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Precise
Placebo
Arm Description
precise PEA therapy with the guide of 3-D imaging techniques
traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method
Outcomes
Primary Outcome Measures
Change from Baseline pulmonary systolic pressure within 1 month
Systolic pulmonary pressure result tested by right-sided heart
Change from Baseline pulmonary mean pressure within 1 month
Mean pulmonary pressure result tested by right-sided heart
Change from Baseline pulmonary vascular resistance within 1 month
Pulmonary vascular resistance result tested by right-sided heart
Change from Baseline cardiac output within 1 month
Cardiac output result tested by right-sided heart
mortality rate after surgery
mortality rate after surgery
Secondary Outcome Measures
Follow-up right ventricular ejection fraction
Assessed by UCG
Follow-up tricuspid annular plane systolic excursion
Assessed by UCG
Follow-up right ventricular anterior-posterior diameter
Assessed by UCG
Follow-up tricuspid insufficiency level
Assessed by UCG
Follow-up peak oxygen consumption (Peak O2) result
Assessed by cardio-pulmonary exercise test (CPET)
Follow-up Peak O2%
Assessed by CPET
Follow-up 6-minutes walking distance
Assessed by CPET
follow-up NYHA classes
NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03795740
Brief Title
Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT
Acronym
PEACT
Official Title
The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sheng Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism
Keywords
computed tomography, chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy, result, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Precise
Arm Type
Experimental
Arm Description
precise PEA therapy with the guide of 3-D imaging techniques
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method
Intervention Type
Diagnostic Test
Intervention Name(s)
3-D CT scanning
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline pulmonary systolic pressure within 1 month
Description
Systolic pulmonary pressure result tested by right-sided heart
Time Frame
within 1 month before and after pulmonary endarterectomy surgery
Title
Change from Baseline pulmonary mean pressure within 1 month
Description
Mean pulmonary pressure result tested by right-sided heart
Time Frame
within 1 month before and after pulmonary endarterectomy surgery
Title
Change from Baseline pulmonary vascular resistance within 1 month
Description
Pulmonary vascular resistance result tested by right-sided heart
Time Frame
within 1 month before and after pulmonary endarterectomy surgery
Title
Change from Baseline cardiac output within 1 month
Description
Cardiac output result tested by right-sided heart
Time Frame
within 1 month before and after pulmonary endarterectomy surgery
Title
mortality rate after surgery
Description
mortality rate after surgery
Time Frame
immediately after the surgery to the longest 48 months follow-up period
Secondary Outcome Measure Information:
Title
Follow-up right ventricular ejection fraction
Description
Assessed by UCG
Time Frame
3-24 months after the surgeries
Title
Follow-up tricuspid annular plane systolic excursion
Description
Assessed by UCG
Time Frame
3-24 months after the surgeries
Title
Follow-up right ventricular anterior-posterior diameter
Description
Assessed by UCG
Time Frame
3-24 months after the surgeries
Title
Follow-up tricuspid insufficiency level
Description
Assessed by UCG
Time Frame
3-24 months after the surgeries
Title
Follow-up peak oxygen consumption (Peak O2) result
Description
Assessed by cardio-pulmonary exercise test (CPET)
Time Frame
6-24 months after the surgeries
Title
Follow-up Peak O2%
Description
Assessed by CPET
Time Frame
6-24 months after the surgeries
Title
Follow-up 6-minutes walking distance
Description
Assessed by CPET
Time Frame
6-24 months after the surgeries
Title
follow-up NYHA classes
Description
NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up
Time Frame
6-24 months after surgeries
10. Eligibility
Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Liu, MD
Phone
13501331366
Email
liusheng@fuwai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiade Zhu, MD
Phone
86-15801204824
Email
15801204824@163.com
Facility Information:
Facility Name
Fuwai Hospital,Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Liu, MD
Phone
86-13501331366
Email
liusheng@fuwai.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have yet no plan to share IPD with other researchers
Citations:
PubMed Identifier
14602267
Citation
Jamieson SW, Kapelanski DP, Sakakibara N, Manecke GR, Thistlethwaite PA, Kerr KM, Channick RN, Fedullo PF, Auger WR. Pulmonary endarterectomy: experience and lessons learned in 1,500 cases. Ann Thorac Surg. 2003 Nov;76(5):1457-62; discussion 1462-4. doi: 10.1016/s0003-4975(03)00828-2.
Results Reference
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PubMed Identifier
15163775
Citation
Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274.
Results Reference
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PubMed Identifier
29563171
Citation
Coquoz N, Weilenmann D, Stolz D, Popov V, Azzola A, Fellrath JM, Stricker H, Pagnamenta A, Ott S, Ulrich S, Gyorik S, Pasquier J, Aubert JD. Multicentre observational screening survey for the detection of CTEPH following pulmonary embolism. Eur Respir J. 2018 Apr 4;51(4):1702505. doi: 10.1183/13993003.02505-2017. Print 2018 Apr.
Results Reference
background
PubMed Identifier
21793646
Citation
Kirson NY, Birnbaum HG, Ivanova JI, Waldman T, Joish V, Williamson T. Prevalence of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in the United States. Curr Med Res Opin. 2011 Sep;27(9):1763-8. doi: 10.1185/03007995.2011.604310. Epub 2011 Jul 27.
Results Reference
background
PubMed Identifier
26826181
Citation
Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.
Results Reference
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PubMed Identifier
24728482
Citation
Inami T, Kataoka M, Ando M, Fukuda K, Yoshino H, Satoh T. A new era of therapeutic strategies for chronic thromboembolic pulmonary hypertension by two different interventional therapies; pulmonary endarterectomy and percutaneous transluminal pulmonary angioplasty. PLoS One. 2014 Apr 11;9(4):e94587. doi: 10.1371/journal.pone.0094587. eCollection 2014.
Results Reference
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PubMed Identifier
21969018
Citation
Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
Results Reference
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Links:
URL
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Description
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Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT
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