<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/NCT03004352</url>
  </required_header>
  <id_info>
    <org_study_id>ED-COPD</org_study_id>
    <nct_id>NCT03004352</nct_id>
  </id_info>
  <brief_title>Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Split, School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Split, School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine if increased retrograde shear would further deteriorate&#xD;
      the already impaired vascular function in severe COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes</measure>
    <time_frame>0,10, 20 and 25 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Microparticle Count at 20 minutes</measure>
    <time_frame>0 and 20 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>control subjects-retrograde flow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retrograde flow was induced in control subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control subjects-control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxemic COPD-retrograde flow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retrograde flow was induced in hypoxemic COPD patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxemic COPD-control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>normoxemic COPD-retrograde flow with oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retrograde flow was induced in COPD patients with normalized arterial oxygen saturation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normoxemic COPD-control with oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPD patients with normalized arterial oxygen saturation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>retrograde flow</intervention_name>
    <description>Two pneumatic cuffs were placed on the experimental arm, one on the lower forearm, and the other on the upper arm. Two cuffs were simultaneously inflated for 20 minutes. The distal cuff was inflated to 75 mm Hg and the proximal cuff was inflated to 40 mm Hg. The contralateral (control) arm was cuff free during this intervention.</description>
    <arm_group_label>control subjects-retrograde flow</arm_group_label>
    <arm_group_label>hypoxemic COPD-retrograde flow</arm_group_label>
    <arm_group_label>normoxemic COPD-retrograde flow with oxygen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>oxygen</intervention_name>
    <description>Supplemental 100% oxygen administered through a nasal cannula.</description>
    <arm_group_label>normoxemic COPD-control with oxygen</arm_group_label>
    <arm_group_label>normoxemic COPD-retrograde flow with oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  chronic hypoxemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  an acute exacerbation, active respiratory infection or infection of other localisation&#xD;
             6 weeks prior to the visit&#xD;
&#xD;
          -  relevant coexisting lung disease such as interstitial lung disease, cancer, renal&#xD;
             failure, thromboembolic disease or major cardiovascular event during the previous year&#xD;
&#xD;
          -  informed consent not provided or inability to comply with the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03004352
org study id: ED-COPD
nct id: NCT03004352
lead sponsor: 
has dmc: No
The aim of the study is to determine if increased retrograde shear would further deteriorate
      the already impaired vascular function in severe COPD patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes
time frame: 0,10, 20 and 25 minutes
measure: Change from Baseline Microparticle Count at 20 minutes
time frame: 0 and 20 minutes
arm group label: control subjects-retrograde flow
arm group type: Experimental
description: Retrograde flow was induced in control subjects.
arm group label: control subjects-control
arm group type: No Intervention
arm group label: hypoxemic COPD-retrograde flow
arm group type: Experimental
description: Retrograde flow was induced in hypoxemic COPD patients.
arm group label: hypoxemic COPD-control
arm group type: No Intervention
arm group label: normoxemic COPD-retrograde flow with oxygen
arm group type: Experimental
description: Retrograde flow was induced in COPD patients with normalized arterial oxygen saturation.
arm group label: normoxemic COPD-control with oxygen
arm group type: Experimental
description: COPD patients with normalized arterial oxygen saturation.
intervention type: Other
intervention name: retrograde flow
description: Two pneumatic cuffs were placed on the experimental arm, one on the lower forearm, and the other on the upper arm. Two cuffs were simultaneously inflated for 20 minutes. The distal cuff was inflated to 75 mm Hg and the proximal cuff was inflated to 40 mm Hg. The contralateral (control) arm was cuff free during this intervention.
arm group label: control subjects-retrograde flow
arm group label: hypoxemic COPD-retrograde flow
arm group label: normoxemic COPD-retrograde flow with oxygen
intervention type: Other
intervention name: oxygen
description: Supplemental 100% oxygen administered through a nasal cannula.
arm group label: normoxemic COPD-control with oxygen
arm group label: normoxemic COPD-retrograde flow with oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No