<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/NCT02193035</url>
  </required_header>
  <id_info>
    <org_study_id>31446114.1.0000.0068</org_study_id>
    <nct_id>NCT02193035</nct_id>
  </id_info>
  <brief_title>Microparticles in Severe Aortic Stenosis</brief_title>
  <official_title>Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InCor Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InCor Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microparticles are small cell fragments that can induce fat plaques, calcification and&#xD;
      formation of thrombus. They can be released through multiple stimulations, but also the high&#xD;
      flow of blood through partially obstructed aortic valves.&#xD;
&#xD;
      In patients with severely obstructed aortic valves the investigators hypothesize that&#xD;
      microparticles levels will be elevated and that they will go down after percutaneous&#xD;
      treatment of the valves.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and&#xD;
      platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient&#xD;
      baseline (including measures of severity of aortic stenosis and its calcification),&#xD;
      procedural data, and clinical evolution will be collected. Inflammatory markers will be&#xD;
      measured, which along with clinical date will be tested for correlation with microparticle&#xD;
      levels.&#xD;
&#xD;
      Patients MPs will be measured before and after percutaneous treatment of the severe aortic&#xD;
      stenosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in microparticle levels</measure>
    <time_frame>Day 5</time_frame>
    <description>Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endothelial microparticle levels</measure>
    <time_frame>Day 5</time_frame>
    <description>Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macrophage microparticle levels</measure>
    <time_frame>Day 5</time_frame>
    <description>Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet microparticle levels</measure>
    <time_frame>Day 5</time_frame>
    <description>Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Single group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microparticle levels</intervention_name>
    <description>Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis</description>
    <arm_group_label>Single group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical indication to be treated with transcatheter aortic valve replacement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non native aortic valve&#xD;
&#xD;
          -  Moderate aortic regurgitation&#xD;
&#xD;
          -  The following complications following valve implantation: patient instability, need&#xD;
             for vasoactive pressors, sepsis and severe infections, stroke.&#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>Pedro Lemos, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Heart Institute - InCor. University of Sao Paulo Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julio F Marchini, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Institute - InCor. University of Sao Paulo Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Institute - InCor. University of Sao Paulo Medical School</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Marchini JF, Miyakawa AA, Tarasoutchi F, Krieger JE, Lemos P, Croce K. Endothelial, platelet, and macrophage microparticle levels do not change acutely following transcatheter aortic valve replacement. J Negat Results Biomed. 2016 Apr 11;15:7. doi: 10.1186/s12952-016-0051-2.</citation>
    <PMID>27063005</PMID>
  </results_reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>April 12, 2016</last_update_submitted>
  <last_update_submitted_qc>April 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>InCor Heart Institute</investigator_affiliation>
    <investigator_full_name>Pedro A. Lemos</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Microparticles</keyword>
  <keyword>Severe aortic stenosis</keyword>
  <keyword>Calcified aortic stenosis</keyword>
  <keyword>transcatheter aortic valve replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT02193035
org study id: 31446114.1.0000.0068
nct id: NCT02193035
lead sponsor: 
has dmc: No
Microparticles are small cell fragments that can induce fat plaques, calcification and
      formation of thrombus. They can be released through multiple stimulations, but also the high
      flow of blood through partially obstructed aortic valves.

      In patients with severely obstructed aortic valves the investigators hypothesize that
      microparticles levels will be elevated and that they will go down after percutaneous
      treatment of the valves.
Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and
      platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient
      baseline (including measures of severity of aortic stenosis and its calcification),
      procedural data, and clinical evolution will be collected. Inflammatory markers will be
      measured, which along with clinical date will be tested for correlation with microparticle
      levels.

      Patients MPs will be measured before and after percutaneous treatment of the severe aortic
      stenosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference in microparticle levels
time frame: Day 5
description: Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
measure: Endothelial microparticle levels
time frame: Day 5
description: Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
measure: Macrophage microparticle levels
time frame: Day 5
description: Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
measure: Platelet microparticle levels
time frame: Day 5
description: Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
arm group label: Single group
arm group type: Experimental
description: Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.
intervention type: Other
intervention name: Microparticle levels
description: Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis
arm group label: Single group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pedro Lemos, MD PhD
role: Study Chair
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
last name: Julio F Marchini, MD PhD
role: Principal Investigator
affiliation: Heart Institute - InCor. University of Sao Paulo Medical School
facility: 
country: Brazil
citation: Marchini JF, Miyakawa AA, Tarasoutchi F, Krieger JE, Lemos P, Croce K. Endothelial, platelet, and macrophage microparticle levels do not change acutely following transcatheter aortic valve replacement. J Negat Results Biomed. 2016 Apr 11;15:7. doi: 10.1186/s12952-016-0051-2.
PMID: 27063005
responsible party type: Principal Investigator
investigator affiliation: InCor Heart Institute
investigator full name: Pedro A. Lemos
investigator title: Professor of Medicine
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No