<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/NCT03759002</url>
  </required_header>
  <id_info>
    <org_study_id>395723</org_study_id>
    <nct_id>NCT03759002</nct_id>
  </id_info>
  <brief_title>Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.</brief_title>
  <official_title>Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</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>
      Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases&#xD;
      (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular&#xD;
      abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been&#xD;
      widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac&#xD;
      mechanics parameters are used to evaluate cardiac function more precisely. However, measuring&#xD;
      CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine&#xD;
      method. Mean platelet volume (MPV) is a hematological index which shows the size of&#xD;
      platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on&#xD;
      people with normal renal function have shown that this parameter can also have association&#xD;
      with CVD. However the data in children with ESRD is scarce. The aim of this study is to find&#xD;
      a simple hematologic marker to use regularly in ESRD children finding patients at risk of&#xD;
      CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT&#xD;
      and cardiac mechanic parameters in children with ESRD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>
  <primary_outcome>
    <measure>MPV in patients and controls</measure>
    <time_frame>1 year after study beginning</time_frame>
    <description>Comparing the mean of MPV in patients and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Echocardiographic indices in patients and controls</measure>
    <time_frame>1.5 years after study beginning</time_frame>
    <description>Comparing the means of echocardiographic indices in patients and controls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carotid intima media thickness in patients and controls</measure>
    <time_frame>2 years after study beginning</time_frame>
    <description>Comparing the mean of carotid intima media thickness in patients and controls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between MPV and ejection fraction</measure>
    <time_frame>1.5 years after study beginning</time_frame>
    <description>Determining correlation between the value of MPV with ejection fraction in patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between MPV and left ventricular mass index</measure>
    <time_frame>1.5 years after study beginning</time_frame>
    <description>Determining correlation between the value of MPV with left ventricular mass index in patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between MPV and strain rate</measure>
    <time_frame>1.5 years after study beginning</time_frame>
    <description>Determining correlation between the value of MPV with strain rate in patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between MPV and global longitudinal strain</measure>
    <time_frame>1.5 years after study beginning</time_frame>
    <description>Determining correlation between the value of MPV with global longitudinal strain in patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between MPV and carotid intima media thickness</measure>
    <time_frame>2 years after study beginning</time_frame>
    <description>Determining correlation between the value of MPV with carotid intima media thickness in patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MPV and thrombotic events</measure>
    <time_frame>2 years after study beginning</time_frame>
    <description>Comparing the values of MPV in patients with and without previous histories of thrombotic events including arteriovenous fistula thrombosis, cerebrovascular accident, deep venous thrombosis, and cerebrovascular accident</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Carotid Intimal Media Thickness</condition>
  <condition>Left Ventricular Hypertrophy</condition>
  <condition>Mean Platelet Volume</condition>
  <condition>End Stage Renal Disease</condition>
  <condition>Hemodialysis Complication</condition>
  <condition>Peritoneal Dialysis Complication</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Children with end stage renal disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Healthy sex- and age adjusted children</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Imaging</intervention_name>
    <description>Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood sampling will performed on all participants for measuring hematological parameters including MPV.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients group will be selected from children who referred to a tertiary care center of&#xD;
        pediatric nephrology diseases.&#xD;
&#xD;
        Controls will be chosen from healthy volunteers who will be visited for medical routine&#xD;
        examination in the hospital staff.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis)&#xD;
             regularly more than 6 months, as case group.&#xD;
&#xD;
          -  Age and gender matched healthy children who have been referred for routine medical&#xD;
             examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled hypertension (until being stabled)&#xD;
&#xD;
          -  Patients on any kind of antithrombotic agents or NSAIDs&#xD;
&#xD;
          -  Severe obesity&#xD;
&#xD;
          -  Diabetes patients&#xD;
&#xD;
          -  Patients with a past history of CVD or stroke in the last 6 months&#xD;
&#xD;
          -  Passive smokers who contacted daily with high smokers in their houses&#xD;
&#xD;
          -  Patients with known hematologic diseases or malignancies (such as Fanconi Anemia)&#xD;
&#xD;
          -  Uncontrolled hypothyroid or hyperthyroid patients&#xD;
&#xD;
          -  Patients with recent (in the last 4 weeks) catheter or exit -site infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaleh Gheissari, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of pediatric nephrology</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Amin Abedini</investigator_full_name>
    <investigator_title>Medical researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hypertrophy, Left Ventricular</mesh_term>
    <mesh_term>Hypertrophy</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/NCT03759002
org study id: 395723
nct id: NCT03759002
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases
      (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular
      abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been
      widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac
      mechanics parameters are used to evaluate cardiac function more precisely. However, measuring
      CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine
      method. Mean platelet volume (MPV) is a hematological index which shows the size of
      platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on
      people with normal renal function have shown that this parameter can also have association
      with CVD. However the data in children with ESRD is scarce. The aim of this study is to find
      a simple hematologic marker to use regularly in ESRD children finding patients at risk of
      CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT
      and cardiac mechanic parameters in children with ESRD.
observational model: Case-Control
time perspective: Cross-Sectional
measure: MPV in patients and controls
time frame: 1 year after study beginning
description: Comparing the mean of MPV in patients and controls.
measure: Echocardiographic indices in patients and controls
time frame: 1.5 years after study beginning
description: Comparing the means of echocardiographic indices in patients and controls
measure: Carotid intima media thickness in patients and controls
time frame: 2 years after study beginning
description: Comparing the mean of carotid intima media thickness in patients and controls
measure: Correlation between MPV and ejection fraction
time frame: 1.5 years after study beginning
description: Determining correlation between the value of MPV with ejection fraction in patients
measure: Correlation between MPV and left ventricular mass index
time frame: 1.5 years after study beginning
description: Determining correlation between the value of MPV with left ventricular mass index in patients
measure: Correlation between MPV and strain rate
time frame: 1.5 years after study beginning
description: Determining correlation between the value of MPV with strain rate in patients
measure: Correlation between MPV and global longitudinal strain
time frame: 1.5 years after study beginning
description: Determining correlation between the value of MPV with global longitudinal strain in patients
measure: Correlation between MPV and carotid intima media thickness
time frame: 2 years after study beginning
description: Determining correlation between the value of MPV with carotid intima media thickness in patients
measure: MPV and thrombotic events
time frame: 2 years after study beginning
description: Comparing the values of MPV in patients with and without previous histories of thrombotic events including arteriovenous fistula thrombosis, cerebrovascular accident, deep venous thrombosis, and cerebrovascular accident
arm group label: Patients
description: Children with end stage renal disease
arm group label: Controls
description: Healthy sex- and age adjusted children
intervention type: Diagnostic Test
intervention name: Imaging
description: Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness
arm group label: Controls
arm group label: Patients
intervention type: Other
intervention name: Blood sampling
description: Blood sampling will performed on all participants for measuring hematological parameters including MPV.
arm group label: Controls
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alaleh Gheissari, M.D.
role: Principal Investigator
affiliation: Professor of pediatric nephrology
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Amin Abedini
investigator title: Medical researcher
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Cardiovascular Diseases
mesh term: Hypertrophy, Left Ventricular
mesh term: Hypertrophy