<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/NCT02265003</url>
  </required_header>
  <id_info>
    <org_study_id>Anaemie</org_study_id>
    <secondary_id>14-016</secondary_id>
    <nct_id>NCT02265003</nct_id>
  </id_info>
  <brief_title>Red Blood Cells as a Reflection of Endothelial Function in Old Age</brief_title>
  <official_title>Red Blood Cells as a Reflection of Endothelial Function in Old Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heinrich-Heine University, Duesseldorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heinrich-Heine University, Duesseldorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to find out, how far red blood cells reflect age-depended changes in&#xD;
      endothelial function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It will be investigated with determination of endothelial function (measured as flow-mediated&#xD;
      vasodilation) and of circulated nitric oxid-pool in red blood cells and in blood plasma, how&#xD;
      far red blood cells reflect age-depended changes in endothelial function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Determination of endothelial function</measure>
    <time_frame>baseline</time_frame>
    <description>measured as flow-mediated vasodilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of nitric oxide(NO)-pool in red blood cells and blood plasma</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of erythrocytes parameter</measure>
    <time_frame>baseline</time_frame>
    <description>It will be determinated: oxidative status, signalling of nitric oxide, function, creation, amount and aging of red blood cells, cell-to-cell-interaction, microRNA and inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Parameter</measure>
    <time_frame>baseline</time_frame>
    <description>It will be determinated: hemodynamic, microcirculation and physicomechanic</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Red Blood Cells</condition>
  <condition>Endothelial Function</condition>
  <condition>Nitric Oxide Pool in Red Blood Cells and Blood Plasma</condition>
  <arm_group>
    <arm_group_label>Healthy young age</arm_group_label>
    <description>Healthy subjects in age of 18-35 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy middle age</arm_group_label>
    <description>Healthy subjects in age of 35-45 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy old</arm_group_label>
    <description>Healthy subjects in age of &gt;70 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with atherosclerosis</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        4 groups:&#xD;
&#xD;
          -  healthy young aged 18-35 years (30 subjects)&#xD;
&#xD;
          -  healthy middel aged 35-45 years (30 subjects)&#xD;
&#xD;
          -  healthy old aged &gt; 70 years (30 subjects)&#xD;
&#xD;
          -  patients (50 subjects)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Groups 1-3:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension (blood pressure ≥140/90 mmHg),&#xD;
&#xD;
          -  hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),&#xD;
&#xD;
          -  diabetes mellitus (fasting plasma glucose ≥128 mg/dl)&#xD;
&#xD;
          -  acute inflammation (CRP &gt;0.5 mg/dl)&#xD;
&#xD;
          -  malignant diseases&#xD;
&#xD;
          -  heart failure (NYHA III-IV)&#xD;
&#xD;
          -  arrhythmia of high degree&#xD;
&#xD;
          -  acute or terminated kidney disease&#xD;
&#xD;
          -  cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and&#xD;
             cerebrovascular diseases)&#xD;
&#xD;
          -  anemia&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
        Group 4 :&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral&#xD;
             vascular disease or degenerative valvular heart disease)&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension (blood pressure ≥140/90 mmHg),&#xD;
&#xD;
          -  Hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),&#xD;
&#xD;
          -  Diabetes mellitus (fasting plasma glucose ≥128 mg/dl)&#xD;
&#xD;
          -  acute inflammation (CRP &gt;0.5 mg/dl)&#xD;
&#xD;
          -  malignant diseases&#xD;
&#xD;
          -  heart failure (NYHA III-IV)&#xD;
&#xD;
          -  arrhythmia of high degree&#xD;
&#xD;
          -  acute or terminated kidney disease&#xD;
&#xD;
          -  cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and&#xD;
             cerebrovascular diseases)&#xD;
&#xD;
          -  anemia&#xD;
&#xD;
          -  pregnancy&#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>
  <overall_official>
    <last_name>Malte Kelm, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Duesseldorf</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heinrich-Heine University, Duesseldorf</investigator_affiliation>
    <investigator_full_name>Klinik für Kardiologie, Pneumologie und Angiologie</investigator_full_name>
    <investigator_title>Principle Investigator Prof. Dr. Malte Kelm</investigator_title>
  </responsible_party>
  <keyword>red blood cells</keyword>
  <keyword>endothelial function</keyword>
  <keyword>nitric oxide pool in red blood cells</keyword>
  <keyword>nitric oxide poll in blood plasma</keyword>
  <keyword>nitric oxide synthase III - expression</keyword>
  <keyword>oxidative status</keyword>
  <keyword>nitric oxide signalling</keyword>
  <!-- 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/NCT02265003
org study id: Anaemie
secondary id: 14-016
nct id: NCT02265003
lead sponsor: 
has dmc: No
The aim of this study is to find out, how far red blood cells reflect age-depended changes in
      endothelial function.
It will be investigated with determination of endothelial function (measured as flow-mediated
      vasodilation) and of circulated nitric oxid-pool in red blood cells and in blood plasma, how
      far red blood cells reflect age-depended changes in endothelial function.
observational model: Cohort
time perspective: Prospective
measure: Determination of endothelial function
time frame: baseline
description: measured as flow-mediated vasodilation
measure: Determination of nitric oxide(NO)-pool in red blood cells and blood plasma
time frame: baseline
measure: Determination of erythrocytes parameter
time frame: baseline
description: It will be determinated: oxidative status, signalling of nitric oxide, function, creation, amount and aging of red blood cells, cell-to-cell-interaction, microRNA and inflammation
measure: Cardiovascular Parameter
time frame: baseline
description: It will be determinated: hemodynamic, microcirculation and physicomechanic
arm group label: Healthy young age
description: Healthy subjects in age of 18-35 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease
arm group label: Healthy middle age
description: Healthy subjects in age of 35-45 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease
arm group label: Healthy old
description: Healthy subjects in age of >70 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease
arm group label: Patients
description: Patients with atherosclerosis
blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Malte Kelm, Prof. MD
role: Principal Investigator
affiliation: Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heinrich-Heine University, Duesseldorf
investigator full name: Klinik für Kardiologie, Pneumologie und Angiologie
investigator title: Principle Investigator Prof. Dr. Malte Kelm