<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/NCT04411888</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH--Pulmonary embolism</org_study_id>
    <nct_id>NCT04411888</nct_id>
  </id_info>
  <brief_title>Pulmonary Embolism Prognosis Model</brief_title>
  <official_title>Observation Study of Clinical Manifestation and Outcome in Chinese Pulmonary Embolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College 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>
      The purpose of this study is to analyze the clinical manifestations, imaging features, and&#xD;
      prognosis-related factors of pulmonary embolism, and to explore the prognosis risk assessment&#xD;
      model for Chinese patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with pulmonary embolism and aged 18 years or older were enrolled in this&#xD;
      study.Patient demographic characteristics((age, sex, department, diagnosis, ), basic vital&#xD;
      signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope), laboratory&#xD;
      examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker),&#xD;
      and imaging examinations (vascular ultrasonography, computed tomographic angiography,&#xD;
      echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT)&#xD;
      were collected by reviewing the cases. The prognostic information was collected by telephone&#xD;
      follow-up. The follow-up end point was June 2024.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient survival time</measure>
    <time_frame>Through study completion, an average of 4 year</time_frame>
    <description>Patient survival time after diagnosed as pulmonary embolism</description>
  </primary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Pulmonary Embolism</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation</intervention_name>
    <description>observation</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients diagnosed as pulmonary embolism who meet the inclusion criteria above.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged 18 years or older. Discharged with the diagnosis of PE from Peking Union Medical&#xD;
        College Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diagnosed PE by other health care facility or transferred from other health care facility .&#xD;
&#xD;
        Without important follow-up data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juhong Shi, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juhong Shi, M.D</last_name>
    <phone>+8613701178492</phone>
    <email>shijh@pumch.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Min Peng, M.D</last_name>
    <phone>+8613581888792</phone>
    <email>pengmin@pumch.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juhong Shi, M.D</last_name>
      <phone>+8613701178492</phone>
      <email>shijh@pumch.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Embolism</keyword>
  <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/NCT04411888
org study id: PUMCH--Pulmonary embolism
nct id: NCT04411888
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to analyze the clinical manifestations, imaging features, and
      prognosis-related factors of pulmonary embolism, and to explore the prognosis risk assessment
      model for Chinese patients
Patients with pulmonary embolism and aged 18 years or older were enrolled in this
      study.Patient demographic characteristics((age, sex, department, diagnosis, ), basic vital
      signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope), laboratory
      examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker),
      and imaging examinations (vascular ultrasonography, computed tomographic angiography,
      echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT)
      were collected by reviewing the cases. The prognostic information was collected by telephone
      follow-up. The follow-up end point was June 2024.
observational model: Case-Only
time perspective: Retrospective
measure: Patient survival time
time frame: Through study completion, an average of 4 year
description: Patient survival time after diagnosed as pulmonary embolism
intervention type: Other
intervention name: observation
description: observation
serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Juhong Shi, M.D
role: Study Chair
affiliation: Peking Union Medical College Hospital
last name: Juhong Shi, M.D
phone: +8613701178492
email: shijh@pumch.cn
last name: Min Peng, M.D
phone: +8613581888792
email: pengmin@pumch.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism