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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: 3-D CT scanning

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Fuwai Hospital,Chinese Academy of Medical Sciences
      • Contact: Sheng Liu, MD; Phone Number: 86-13501331366; Email: liusheng@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheng Liu

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• a website could find all the citation above,enter the website of "https://www.ncbi.nlm.nih.gov/pubmed",input the PubMed ID of corresponding citation,and the citation will be shown in the webpage.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; computed tomography; chronic thromboembolic pulmonary hypertension; pulmonary endarterectomy; result
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Embolism; Hypertension, Pulmonary; Pulmonary Embolism
• Other Study ID Numbers: liusheng-1999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We have yet no plan to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No