<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/NCT03782870</url>
  </required_header>
  <id_info>
    <org_study_id>AKBE/130/2018</org_study_id>
    <nct_id>NCT03782870</nct_id>
  </id_info>
  <brief_title>Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis</brief_title>
  <official_title>Clinical and Echocardiographic Evaluation of Patients With Granulomatosis With Polyangiitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</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>
      Granulomatosis with polyangiitis (GPA) is one of antineutrophil cytoplasmic autoantibody&#xD;
      (ANCA) - associated vasculitis. Inflammation-induced thrombosis is considered to be a feature&#xD;
      of systemic autoimmune diseases. GPA usually involves the upper and lower respiratory tract&#xD;
      and renal systems, where necrotizing glomerulonephritis and pulmonary capillaritis are often&#xD;
      detected. However, it may also affect other organ systems. Cardiac involvement in GPA occurs&#xD;
      in approximately 6% to 44% of cases and is secondary to necrotizing vasculitis with&#xD;
      granulomatous infiltrates. Cardiac involvement is an independent predictor of mortality in&#xD;
      GPA patients. In this prospective cohort study, consecutive GPA patients who were&#xD;
      hospitalized in the Department of Family Medicine, Internal and Metabolic Diseases at the&#xD;
      Medical University of Warsaw in Poland are included. In all patients echocardiography and&#xD;
      laboratory tests are perform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Granulomatosis with polyangiitis (Wegener's; GPA) is an antineutrophil cytoplasmic antibody&#xD;
      (ANCA)-associated vasculitis (AAV), which also includes microscopic polyangiitis and&#xD;
      eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). GPA is characterized&#xD;
      by granulomatous inflammation and necrotizing vasculitis predominantly affecting small- to&#xD;
      medium-sized blood vessels and the presence of ANCA directed to specific antigens,&#xD;
      particularly proteinase 3 (PR3-ANCA) and myeloperoxidase (MPO-ANCA). The destructive&#xD;
      inflammatory processes of GPA have a predilection for the upper and lower airways and the&#xD;
      kidneys, but any organs can be affected. An increased incidence of various cardiovascular&#xD;
      events has been demonstrated among GPA patients. Cardiac involvement is also an independent&#xD;
      predictor of mortality in GPA patients. In this prospective cohort study, consecutive GPA&#xD;
      patients who are hospitalized in the Department of Family Medicine, Internal and Metabolic&#xD;
      Diseases at the Medical University of Warsaw in Poland are included. All patients are&#xD;
      diagnosed with GPA according to current guidelines. Patients are entered into the study at&#xD;
      the time point when a new diagnosis of GPA was established and received initial treatment at&#xD;
      our centre. Data collection included a full interim medical history, physical examination,&#xD;
      laboratory studies and review of adverse events. Additionally, in all patients an&#xD;
      echocardiography is performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2010</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</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>death from any cause</measure>
    <time_frame>from date of randomization until the death from any cause, up to december 2018</time_frame>
    <description>death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>coronary artery disease</measure>
    <time_frame>from date of randomization until the date of first documented coronary artery disease episodes up to december 2018</time_frame>
    <description>coronarography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke</measure>
    <time_frame>from date of randomization until the date of documented stroke, up to december 2018</time_frame>
    <description>CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>deep vein thrombosis</measure>
    <time_frame>from date of randomization until the date of documented deep vein thrombosis, up to december 2018</time_frame>
    <description>Ultrasonography of the lower extremity veins</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Granulomatosis With Polyangiitis</condition>
  <condition>Atherosclerosis</condition>
  <condition>Thrombosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>echocardiography, lab tests</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly diagnosed Granulomatosis with polyangitis who received initial&#xD;
        treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed Granulomatosis with polyangitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Borowiec, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Warsaw University of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Borowiec, PhD</last_name>
    <phone>+48225720913</phone>
    <email>ania_borowiec@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Family Medicine, Internal and Metabolic Diseases</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Borowiec, PhD</last_name>
      <phone>48225720913</phone>
      <email>ania_borowiec@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>granulomatosis with polyangitis, cardiac involvement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Granulomatosis with Polyangiitis</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Systemic Vasculitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03782870
org study id: AKBE/130/2018
nct id: NCT03782870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Granulomatosis with polyangiitis (GPA) is one of antineutrophil cytoplasmic autoantibody
      (ANCA) - associated vasculitis. Inflammation-induced thrombosis is considered to be a feature
      of systemic autoimmune diseases. GPA usually involves the upper and lower respiratory tract
      and renal systems, where necrotizing glomerulonephritis and pulmonary capillaritis are often
      detected. However, it may also affect other organ systems. Cardiac involvement in GPA occurs
      in approximately 6% to 44% of cases and is secondary to necrotizing vasculitis with
      granulomatous infiltrates. Cardiac involvement is an independent predictor of mortality in
      GPA patients. In this prospective cohort study, consecutive GPA patients who were
      hospitalized in the Department of Family Medicine, Internal and Metabolic Diseases at the
      Medical University of Warsaw in Poland are included. In all patients echocardiography and
      laboratory tests are perform.
Granulomatosis with polyangiitis (Wegener's; GPA) is an antineutrophil cytoplasmic antibody
      (ANCA)-associated vasculitis (AAV), which also includes microscopic polyangiitis and
      eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). GPA is characterized
      by granulomatous inflammation and necrotizing vasculitis predominantly affecting small- to
      medium-sized blood vessels and the presence of ANCA directed to specific antigens,
      particularly proteinase 3 (PR3-ANCA) and myeloperoxidase (MPO-ANCA). The destructive
      inflammatory processes of GPA have a predilection for the upper and lower airways and the
      kidneys, but any organs can be affected. An increased incidence of various cardiovascular
      events has been demonstrated among GPA patients. Cardiac involvement is also an independent
      predictor of mortality in GPA patients. In this prospective cohort study, consecutive GPA
      patients who are hospitalized in the Department of Family Medicine, Internal and Metabolic
      Diseases at the Medical University of Warsaw in Poland are included. All patients are
      diagnosed with GPA according to current guidelines. Patients are entered into the study at
      the time point when a new diagnosis of GPA was established and received initial treatment at
      our centre. Data collection included a full interim medical history, physical examination,
      laboratory studies and review of adverse events. Additionally, in all patients an
      echocardiography is performed.
observational model: Cohort
time perspective: Prospective
measure: death from any cause
time frame: from date of randomization until the death from any cause, up to december 2018
description: death
measure: coronary artery disease
time frame: from date of randomization until the date of first documented coronary artery disease episodes up to december 2018
description: coronarography
measure: stroke
time frame: from date of randomization until the date of documented stroke, up to december 2018
description: CT scan
measure: deep vein thrombosis
time frame: from date of randomization until the date of documented deep vein thrombosis, up to december 2018
description: Ultrasonography of the lower extremity veins
intervention type: Diagnostic Test
intervention name: echocardiography, lab tests
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Borowiec, PhD
role: Study Chair
affiliation: Warsaw University of Medicine
last name: Anna Borowiec, PhD
phone: +48225720913
email: ania_borowiec@yahoo.com
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Sponsor
mesh term: Granulomatosis with Polyangiitis
mesh term: Thrombosis
mesh term: Atherosclerosis
mesh term: Systemic Vasculitis
sharing ipd: Undecided