<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/NCT01671306</url>
  </required_header>
  <id_info>
    <org_study_id>1037</org_study_id>
    <secondary_id>Samsun EAH</secondary_id>
    <nct_id>NCT01671306</nct_id>
  </id_info>
  <brief_title>The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus</brief_title>
  <official_title>The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsun Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsun Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral&#xD;
      development in non-diabetic patients with stable coronary artery disease. Our aim in this&#xD;
      study is to find out any possible relationship between the levels of circulating monocyte&#xD;
      subsets and coronary collateral development in type 2 diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      83 diabetic patients with severe coronary artery disease were enrolled in the study. These&#xD;
      patients were investigated according to their collateral development. Monocytes and their&#xD;
      subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">83</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Collateral, coronary disease</arm_group_label>
    <description>Patients are grouped into 2: Good and poor collateral development</description>
  </arm_group>
  <arm_group>
    <arm_group_label>collateral</arm_group_label>
    <description>Patients are grouped into 2: Good and poor collateral development</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consisted of 83 consecutive type 2 diabetic patients who have&#xD;
        undergone coronary angiography because of stable symptoms and signs of coronary artery&#xD;
        disease. The main inclusion criterion was the presence of &gt;95% stenosis of at least one&#xD;
        major coronary artery in their first coronary angiogram.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of &gt; 95% stenosis of at least one major coronary artery in their first&#xD;
             coronary angiogram.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients experiencing acute coronary syndrome either with or without ST elevation in&#xD;
             the last one month&#xD;
&#xD;
          -  Evidence of ongoing infection and inflammation, known malignancy and chronic kidney&#xD;
             disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uğur ARSLAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsun Education and Research Hospital</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsun Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ugur ARSLAN</investigator_full_name>
    <investigator_title>Specialist of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Coronary collaterals</keyword>
  <keyword>diabetes mellitus</keyword>
  <keyword>monocyte subsets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</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/NCT01671306
org study id: 1037
secondary id: Samsun EAH
nct id: NCT01671306
lead sponsor: 
has dmc: No
Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral
      development in non-diabetic patients with stable coronary artery disease. Our aim in this
      study is to find out any possible relationship between the levels of circulating monocyte
      subsets and coronary collateral development in type 2 diabetic patients.
83 diabetic patients with severe coronary artery disease were enrolled in the study. These
      patients were investigated according to their collateral development. Monocytes and their
      subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups
observational model: Case-Control
time perspective: Cross-Sectional
arm group label: Collateral, coronary disease
description: Patients are grouped into 2: Good and poor collateral development
arm group label: collateral
description: Patients are grouped into 2: Good and poor collateral development
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Uğur ARSLAN, MD
role: Principal Investigator
affiliation: Samsun Education and Research Hospital
responsible party type: Principal Investigator
investigator affiliation: Samsun Education and Research Hospital
investigator full name: Ugur ARSLAN
investigator title: Specialist of Cardiology
mesh term: Coronary Artery Disease
mesh term: Diabetes Mellitus