<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/NCT02214043</url>
  </required_header>
  <id_info>
    <org_study_id>APEINCP</org_study_id>
    <nct_id>NCT02214043</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population</brief_title>
  <official_title>Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Pulmonary Vascular Disease Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Pulmonary Vascular Disease Research Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are no special clinical characteristics of acute pulmonary embolism in Chinese&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The second end point was death (all cause death and PE-related death).</measure>
    <time_frame>60 months</time_frame>
    <description>If the participant died, the relatives need provided the written medical record on the death.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      BNP，D-dimer&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Acute pulmonary embolism in Chinese population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the symptomatic acute PE confirmed by objective examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congestive heart failure&#xD;
&#xD;
          -  chronic obstructive pulmonary disease;&#xD;
&#xD;
          -  a prior documented episode of PE or DVT&#xD;
&#xD;
          -  renal dysfunction;&#xD;
&#xD;
          -  a life expectancy of less than 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhihong Liu, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese pulmonary vascular disease organization group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center of pumonary vascular diseases</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>February 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>January 28, 2018</last_update_submitted>
  <last_update_submitted_qc>January 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <!-- 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/NCT02214043
org study id: APEINCP
nct id: NCT02214043
lead sponsor: 
has dmc: Yes
There are no special clinical characteristics of acute pulmonary embolism in Chinese
      population.
observational model: Cohort
time perspective: Prospective
measure: The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.
time frame: 60 months
measure: The second end point was death (all cause death and PE-related death).
time frame: 60 months
description: If the participant died, the relatives need provided the written medical record on the death.
arm group label: Group 2
arm group label: group 1
BNP，D-dimer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 85 Years
healthy volunteers: No
last name: Zhihong Liu, Doctor
role: Study Chair
affiliation: Chinese pulmonary vascular disease organization group
facility: 
country: China
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism