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

Pulmonary Embolism Clinical Trial

— PEACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795740
• Other study ID #: liusheng-1999
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Sheng Liu, MD
• Phone: 13501331366
• Email: liusheng[@]fuwai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Embolism
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital,Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sheng Liu

Country where clinical trial is conducted

China, 

References & Publications (7)

Coquoz N, Weilenmann D, Stolz D, Popov V, Azzola A, Fellrath JM, Stricker H, Pagnamenta A, Ott S, Ulrich S, Györik 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). pii: 1702505. doi: 10.1183/13993003.02505-2017. Print 2018 Apr. — View 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, Barberà JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jaïs 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. — View 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. — View 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. — View 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. — View 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. — View 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, Barberà JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jaïs 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	mortality rate after surgery	mortality rate after surgery	immediately after the surgery to the longest 48 months follow-up period
Secondary	Follow-up right ventricular ejection fraction	Assessed by UCG	3-24 months after the surgeries
Secondary	Follow-up tricuspid annular plane systolic excursion	Assessed by UCG	3-24 months after the surgeries
Secondary	Follow-up right ventricular anterior-posterior diameter	Assessed by UCG	3-24 months after the surgeries
Secondary	Follow-up tricuspid insufficiency level	Assessed by UCG	3-24 months after the surgeries
Secondary	Follow-up peak oxygen consumption (Peak O2) result	Assessed by cardio-pulmonary exercise test (CPET)	6-24 months after the surgeries
Secondary	Follow-up Peak O2%	Assessed by CPET	6-24 months after the surgeries
Secondary	Follow-up 6-minutes walking distance	Assessed by CPET	6-24 months after the surgeries
Secondary	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

External 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.