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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precise | Experimental | precise PEA therapy with the guide of 3-D imaging techniques |
|
| Placebo | Placebo Comparator | traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Liu, MD | Contact | 13501331366 | liusheng@fuwai.com | |
| Jiade Zhu, MD | Contact | 86-15801204824 | 15801204824@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital,Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14602267 | Background | 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. | |
| 15163775 | Background |
| Label | URL |
|---|---|
| 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. | View source |
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We have yet no plan to share IPD with other researchers
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2018 | Jan 4, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2018 | Jan 4, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| 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 |
| 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. |
| 29563171 | 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. |
| 21793646 | 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. |
| 26826181 | 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. |
| 24728482 | 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. |
| 21969018 | 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. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |