<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/NCT01717092</url>
  </required_header>
  <id_info>
    <org_study_id>XJ-CTPH20121026</org_study_id>
    <nct_id>NCT01717092</nct_id>
  </id_info>
  <brief_title>Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable&#xD;
      morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors&#xD;
      are not well documented in Chinese population. We conducted a prospective, long-term,&#xD;
      follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an&#xD;
      acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with&#xD;
      unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and,&#xD;
      if supportive findings were present, ventilation-perfusion lung scanning and pulmonary&#xD;
      angiography. CTPH was considered to be present if systolic and mean pulmonary-artery&#xD;
      pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure&#xD;
      was normal; and there was angiographic evidence of disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The cumulative incidence of symptomatic CTEPH</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for Recurrent VTE and CTEPH</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>To Assess the Long-term Risk for Adverse Events After PE.</condition>
  <arm_group>
    <arm_group_label>Consecutive patients with acute PE</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with an acute episode of pulmonary embolism but without prior venous&#xD;
        thromboembolism.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an episode of acute symptomatic pulmonary embolism without prior&#xD;
             pulmonary embolism or venous thrombosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have&#xD;
             caused nonthromboembolic pulmonary hypertension,&#xD;
&#xD;
          -  Have preexisting exertional dyspnea,&#xD;
&#xD;
          -  Geographically inaccessible for follow-up,&#xD;
&#xD;
          -  Decline to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shengqing Li, MD, PhD</last_name>
    <phone>+86-29-84771132</phone>
    <email>shengqingli@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tangdu hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yonghong Xie, MD</last_name>
      <phone>+86-29-84777725</phone>
      <email>xieyh65@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xijing hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongping Yu, MD</last_name>
      <phone>+86-29-84771132</phone>
      <email>yuyongping_6100@163.com</email>
    </contact>
    <investigator>
      <last_name>Yongping Yu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xinpeng Han, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>February 26, 2014</last_update_submitted>
  <last_update_submitted_qc>February 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Shengqing Li</investigator_full_name>
    <investigator_title>MD, PhD, Associate Chief Physician, Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01717092
org study id: XJ-CTPH20121026
nct id: NCT01717092
lead sponsor: 
has dmc: Yes
Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable
      morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors
      are not well documented in Chinese population. We conducted a prospective, long-term,
      follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an
      acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with
      unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and,
      if supportive findings were present, ventilation-perfusion lung scanning and pulmonary
      angiography. CTPH was considered to be present if systolic and mean pulmonary-artery
      pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure
      was normal; and there was angiographic evidence of disease.
observational model: Cohort
time perspective: Prospective
measure: The cumulative incidence of symptomatic CTEPH
time frame: 2 years
measure: Risk factors for Recurrent VTE and CTEPH
time frame: 2 years
arm group label: Consecutive patients with acute PE
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shengqing Li, MD, PhD
phone: +86-29-84771132
email: shengqingli@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Shengqing Li
investigator title: MD, PhD, Associate Chief Physician, Associate Professor