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

NCT03795740 | Unknown DMC

• 1 other identifier: liusheng-1999
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Embolism

Keywords

computed tomography; chronic thromboembolic pulmonary hypertension; pulmonary endarterectomy; result; randomized controlled trial

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Follow-up right ventricular ejection fraction

  3-24 months after the surgeries

• Follow-up tricuspid annular plane systolic excursion

  3-24 months after the surgeries

• Follow-up right ventricular anterior-posterior diameter

  3-24 months after the surgeries

• Follow-up tricuspid insufficiency level

  3-24 months after the surgeries

• Follow-up peak oxygen consumption (Peak O2) result

  6-24 months after the surgeries

Study Arms (2)

Precise

EXPERIMENTAL

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

Diagnostic Test: 3-D CT scanning

Placebo

PLACEBO COMPARATOR

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

Diagnostic Test: 3-D CT scanning

Interventions

3-D CT scanning DIAGNOSTIC_TEST

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; Precise

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sheng Liu: lead

Study Sites (1)

Fuwai Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 14602267 BACKGROUND

• 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.

  PMID: 15163775 BACKGROUND

• 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.

  PMID: 29563171 BACKGROUND

• 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.

  PMID: 21793646 BACKGROUND

• 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.

  PMID: 26826181 BACKGROUND

• 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.

  PMID: 24728482 BACKGROUND

• 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.

  PMID: 21969018 BACKGROUND

Related 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.

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sheng Liu, MD

CONTACT

13501331366; liusheng@fuwai.com

Jiade Zhu, MD

CONTACT

86-15801204824; 15801204824@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adult Cardiac Surgery Center

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 8, 2019
• Study Start: February 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2022
• Last Updated: January 8, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)