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

NCT ID: NCT03795740

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Thromboembolic Pulmonary Hypertension Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Precise

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

Group Type EXPERIMENTAL

3-D CT scanning

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

3-D CT scanning

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheng Liu

OTHER

Sponsor Role lead

Responsible Party

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Sheng Liu

Adult Cardiac Surgery Center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fuwai Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sheng Liu, MD

Role: CONTACT

13501331366

Jiade Zhu, MD

Role: CONTACT

86-15801204824

Facility Contacts

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Sheng Liu, MD

Role: primary

86-13501331366

References

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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.

Reference Type BACKGROUND
PMID: 14602267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15163775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29563171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21793646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26826181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24728482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21969018 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed

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Other Identifiers

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liusheng-1999

Identifier Type: -

Identifier Source: org_study_id

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