<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/NCT01672203</url>
  </required_header>
  <id_info>
    <org_study_id>UKK-PostLE</org_study_id>
    <nct_id>NCT01672203</nct_id>
  </id_info>
  <brief_title>Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism</brief_title>
  <official_title>Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased&#xD;
      morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for&#xD;
      development of CTEPH. It is not known, whether the location of pulmonary embolism (central&#xD;
      vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been&#xD;
      performed to assess the CTEPH incidence in different populations: in patients with central&#xD;
      vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The embolus localization during index pulmonary embolism might be of potential relevance for&#xD;
      CTEPH development.&#xD;
&#xD;
      In the present study patients with confirmed pulmonary embolism for at least 12 months will&#xD;
      be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location&#xD;
      (central vs. peripheral) and the index use of fibrinolysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2009</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CTEPH</measure>
    <time_frame>participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated</time_frame>
    <description>Incidence of CTEPH</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>CTEPH</condition>
  <arm_group>
    <arm_group_label>PE peripheral with fibrinolysis</arm_group_label>
    <description>Patients with peripheral PE who received fibrinolysis therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PE peripheral, no fibrinolysis</arm_group_label>
    <description>Patients with peripheral PE who did not receive fibrinolysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PE central with fibrinolysis</arm_group_label>
    <description>Patients with central PE who received fibrinolysis therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PE central, no fibrinolysis</arm_group_label>
    <description>Patients with central PE who did not receive fibrinolysis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were hospitalized for acute pulmonary embolism at the University Hospital of&#xD;
        Cologne.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute pulmonary embolism for at least 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known pulmonary hypertension other than CTEPH&#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>Fikret Er, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cologne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fikret Er, MD</last_name>
    <phone>+49-221-478-32396</phone>
    <email>fikret.er@uk-koeln.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natig Gassanov, MD</last_name>
    <phone>+49-221-478-32354</phone>
    <email>natig.gassanov@uk-koeln.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Heart Center of the University Hospital of Cologne</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fikret Er, MD</last_name>
      <phone>+49-221-47832396</phone>
      <email>fikret.er@uk-koeln.de</email>
    </contact>
    <investigator>
      <last_name>Fikret Er, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 23, 2012</last_update_submitted>
  <last_update_submitted_qc>August 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Dr. Fikret Er</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01672203
org study id: UKK-PostLE
nct id: NCT01672203
lead sponsor: 
has dmc: Yes
Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased
      morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for
      development of CTEPH. It is not known, whether the location of pulmonary embolism (central
      vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been
      performed to assess the CTEPH incidence in different populations: in patients with central
      vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.
The embolus localization during index pulmonary embolism might be of potential relevance for
      CTEPH development.

      In the present study patients with confirmed pulmonary embolism for at least 12 months will
      be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location
      (central vs. peripheral) and the index use of fibrinolysis.
observational model: Case-Control
time perspective: Prospective
measure: CTEPH
time frame: participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated
description: Incidence of CTEPH
arm group label: PE peripheral with fibrinolysis
description: Patients with peripheral PE who received fibrinolysis therapy
arm group label: PE peripheral, no fibrinolysis
description: Patients with peripheral PE who did not receive fibrinolysis
arm group label: PE central with fibrinolysis
description: Patients with central PE who received fibrinolysis therapy
arm group label: PE central, no fibrinolysis
description: Patients with central PE who did not receive fibrinolysis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Fikret Er, MD
role: Principal Investigator
affiliation: University of Cologne
last name: Fikret Er, MD
phone: +49-221-478-32396
email: fikret.er@uk-koeln.de
last name: Natig Gassanov, MD
phone: +49-221-478-32354
email: natig.gassanov@uk-koeln.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Dr. Fikret Er
investigator title: MD
mesh term: Embolism