<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03795740</url>
  </required_header>
  <id_info>
    <org_study_id>liusheng-1999</org_study_id>
    <nct_id>NCT03795740</nct_id>
  </id_info>
  <brief_title>Pulmonary Endarterectomy Guided by CT Scanning for Patients With Chronic Thromboembolic Pulmonary Hypertension----PEACT</brief_title>
  <acronym>PEACT</acronym>
  <official_title>The Precise Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension: Pulmonary Endarterectomy Guided by Three-dimensional Pulmonary Angiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheng Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a effectiveness study of the application of high-definition enhanced&#xD;
      computed-tomography for patients with chronic thromboembolic pulmonary&#xD;
      hypertension(CTEPH).The patients with CTEPH was randomized into 2 groups,precise pulmonary&#xD;
      endarterectomy group(guided by enhanced CT scanning) and traditional pulmonary endarterectomy&#xD;
      group,the hemodynamic changes tested with right sided heart catherization from baseline to&#xD;
      post-operative period and end-point including peri-operative deaths,follow-up&#xD;
      mortality,follow-up parameters of ultrasonic cardiogram(UCG),right-sided heart&#xD;
      catherization(RHC),nuclear magnetic resonance imaging(MRI),cardiac pulmonary exercise&#xD;
      test(CPET) are documented,so as to compare the prognosis between these 2 groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline pulmonary systolic pressure within 1 month</measure>
    <time_frame>within 1 month before and after pulmonary endarterectomy surgery</time_frame>
    <description>Systolic pulmonary pressure result tested by right-sided heart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline pulmonary mean pressure within 1 month</measure>
    <time_frame>within 1 month before and after pulmonary endarterectomy surgery</time_frame>
    <description>Mean pulmonary pressure result tested by right-sided heart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline pulmonary vascular resistance within 1 month</measure>
    <time_frame>within 1 month before and after pulmonary endarterectomy surgery</time_frame>
    <description>Pulmonary vascular resistance result tested by right-sided heart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline cardiac output within 1 month</measure>
    <time_frame>within 1 month before and after pulmonary endarterectomy surgery</time_frame>
    <description>Cardiac output result tested by right-sided heart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality rate after surgery</measure>
    <time_frame>immediately after the surgery to the longest 48 months follow-up period</time_frame>
    <description>mortality rate after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follow-up right ventricular ejection fraction</measure>
    <time_frame>3-24 months after the surgeries</time_frame>
    <description>Assessed by UCG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up tricuspid annular plane systolic excursion</measure>
    <time_frame>3-24 months after the surgeries</time_frame>
    <description>Assessed by UCG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up right ventricular anterior-posterior diameter</measure>
    <time_frame>3-24 months after the surgeries</time_frame>
    <description>Assessed by UCG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up tricuspid insufficiency level</measure>
    <time_frame>3-24 months after the surgeries</time_frame>
    <description>Assessed by UCG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up peak oxygen consumption (Peak O2) result</measure>
    <time_frame>6-24 months after the surgeries</time_frame>
    <description>Assessed by cardio-pulmonary exercise test (CPET)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up Peak O2%</measure>
    <time_frame>6-24 months after the surgeries</time_frame>
    <description>Assessed by CPET</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up 6-minutes walking distance</measure>
    <time_frame>6-24 months after the surgeries</time_frame>
    <description>Assessed by CPET</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>follow-up NYHA classes</measure>
    <time_frame>6-24 months after surgeries</time_frame>
    <description>NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Chronic Thromboembolic Pulmonary Hypertension</condition>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Precise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>precise PEA therapy with the guide of 3-D imaging techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>3-D CT scanning</intervention_name>
    <description>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</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Precise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Definite diagnosed with chronic thromboembolic pulmonary hypertension with the&#xD;
             right-sided cathrization and pulmonary angiography;&#xD;
&#xD;
          -  The computed tomography imaging implied that the location of the embolism could be&#xD;
             reached with surgeries;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Beyond the age limit described above,or combined with other severe conditions such as&#xD;
             severe organ dysfunction and considered contraindicated for surgical therapy by the&#xD;
             cardiac surgeons;&#xD;
&#xD;
          -  Without the consent by the patient or his/her families;&#xD;
&#xD;
          -  Acute pulmonary embolism;&#xD;
&#xD;
          -  Pulmonary sarcoma;&#xD;
&#xD;
          -  Pulmonary arteritis;&#xD;
&#xD;
          -  Combined with cardiogenic pulmonary hypertension or idiopathic pulmonary hypertension;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sheng Liu, MD</last_name>
    <phone>13501331366</phone>
    <email>liusheng@fuwai.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jiade Zhu, MD</last_name>
    <phone>86-15801204824</phone>
    <email>15801204824@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuwai Hospital,Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheng Liu, MD</last_name>
      <phone>86-13501331366</phone>
      <email>liusheng@fuwai.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed</url>
    <description>a website could find all the citation above,enter the website of &quot;https://www.ncbi.nlm.nih.gov/pubmed&quot;,input the PubMed ID of corresponding citation,and the citation will be shown in the webpage.</description>
  </link>
  <reference>
    <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. doi: 10.1016/s0003-4975(03)00828-2.</citation>
    <PMID>14602267</PMID>
  </reference>
  <reference>
    <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. doi: 10.1056/NEJMoa032274.</citation>
    <PMID>15163775</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29563171</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21793646</PMID>
  </reference>
  <reference>
    <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, 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.</citation>
    <PMID>26826181</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24728482</PMID>
  </reference>
  <reference>
    <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, 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.</citation>
    <PMID>21969018</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Sheng Liu</investigator_full_name>
    <investigator_title>Adult Cardiac Surgery Center</investigator_title>
  </responsible_party>
  <keyword>computed tomography</keyword>
  <keyword>chronic thromboembolic pulmonary hypertension</keyword>
  <keyword>pulmonary endarterectomy</keyword>
  <keyword>result</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We have yet no plan to share IPD with other researchers</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03795740/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03795740/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03795740
org study id: liusheng-1999
nct id: NCT03795740
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline pulmonary systolic pressure within 1 month
time frame: within 1 month before and after pulmonary endarterectomy surgery
description: Systolic pulmonary pressure result tested by right-sided heart
measure: Change from Baseline pulmonary mean pressure within 1 month
time frame: within 1 month before and after pulmonary endarterectomy surgery
description: Mean pulmonary pressure result tested by right-sided heart
measure: Change from Baseline pulmonary vascular resistance within 1 month
time frame: within 1 month before and after pulmonary endarterectomy surgery
description: Pulmonary vascular resistance result tested by right-sided heart
measure: Change from Baseline cardiac output within 1 month
time frame: within 1 month before and after pulmonary endarterectomy surgery
description: Cardiac output result tested by right-sided heart
measure: mortality rate after surgery
time frame: immediately after the surgery to the longest 48 months follow-up period
description: mortality rate after surgery
measure: Follow-up right ventricular ejection fraction
time frame: 3-24 months after the surgeries
description: Assessed by UCG
measure: Follow-up tricuspid annular plane systolic excursion
time frame: 3-24 months after the surgeries
description: Assessed by UCG
measure: Follow-up right ventricular anterior-posterior diameter
time frame: 3-24 months after the surgeries
description: Assessed by UCG
measure: Follow-up tricuspid insufficiency level
time frame: 3-24 months after the surgeries
description: Assessed by UCG
measure: Follow-up peak oxygen consumption (Peak O2) result
time frame: 6-24 months after the surgeries
description: Assessed by cardio-pulmonary exercise test (CPET)
measure: Follow-up Peak O2%
time frame: 6-24 months after the surgeries
description: Assessed by CPET
measure: Follow-up 6-minutes walking distance
time frame: 6-24 months after the surgeries
description: Assessed by CPET
measure: follow-up NYHA classes
time frame: 6-24 months after surgeries
description: NYHA classes in the follow up period,either with telephone follow-up or out-patient follow up
arm group label: Precise
arm group type: Experimental
description: precise PEA therapy with the guide of 3-D imaging techniques
arm group label: Placebo
arm group type: Placebo Comparator
description: traditional PEA therapy solely by surgical probe and traditional CT scanning/pulmonary angiography method
intervention type: Diagnostic Test
intervention name: 3-D CT scanning
description: 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
arm group label: Placebo
arm group label: Precise
criteria: 
gender: All
minimum age: N/A
maximum age: 85 Years
healthy volunteers: No
last name: Sheng Liu, MD
phone: 13501331366
email: liusheng@fuwai.com
last name: Jiade Zhu, MD
phone: 86-15801204824
email: 15801204824@163.com
facility: 
status: Recruiting
contact: 
country: China
url: https://www.ncbi.nlm.nih.gov/pubmed
description: 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.
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. doi: 10.1016/s0003-4975(03)00828-2.
PMID: 14602267
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. doi: 10.1056/NEJMoa032274.
PMID: 15163775
citation: 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
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.
PMID: 21793646
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, 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
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.
PMID: 24728482
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, 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
responsible party type: Sponsor-Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Sheng Liu
investigator title: Adult Cardiac Surgery Center
mesh term: Hypertension, Pulmonary
mesh term: Pulmonary Embolism
mesh term: Hypertension
mesh term: Embolism
sharing ipd: No
ipd description: We have yet no plan to share IPD with other researchers
provided document: 
provided document: 