<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/NCT02192372</url>
  </required_header>
  <id_info>
    <org_study_id>MetS CIN</org_study_id>
    <nct_id>NCT02192372</nct_id>
  </id_info>
  <brief_title>Metabolic Syndrome and Contrast Induced Nephropathy</brief_title>
  <official_title>Impact of Metabolic Syndrome on Development of Contrast Induced Nephropathy After Elective Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prevention of contrast induced nephropathy after interventional cardiologic procedures&#xD;
      deserves close interest because of its association with prolonged hospitalization, increased&#xD;
      cost and increased in hospital and long term mortality rates. An observational prospective&#xD;
      cohort study was designed to determine whether metabolic syndrome predicts the development of&#xD;
      contrast induced nephropathy after elective percutaneous coronary intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Contrast induced nephropathy</measure>
    <time_frame>24-48 hours after the percutaneous coronary intervention</time_frame>
    <description>Contrast induced nephropathy was defined as an increase in serum creatinine of &gt;25% or &gt;0.5 mg/dl above the baseline value 24 or 48 hours after angiography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>glomerular filtration rate</measure>
    <time_frame>48 hours after the percutaneous coronary intervention</time_frame>
    <description>Glomerular filtration rate was estimated using the Cockcroft-Gault formula: (140-age) x weight (kg)/ serum creatinine (mg/dl) x 72 (x 0.85 for females)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cut-off point for baseline glomerular filtration rate to predict development of contrast induced nephropathy</measure>
    <time_frame>baseline glomerular filtration rate</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">599</enrollment>
  <condition>Contrast Induced Nephropathy</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>metabolic syndrome</arm_group_label>
    <description>Presence of 3 or more of these components: high fasting glucose (fasting serum glucose ≥ 100 mg/dl or drug treatment for elevated blood glucose), abdominal obesity (given as waist circumference &gt; 102 cm in men and &gt; 88 cm in women), high blood pressure (≥130/≥85 mmHg or drug treatment for hypertension), hypertriglyceridemia (serum triglycerides ≥150 mg/dl), low high-density lipoprotein cholesterol (&lt;40 mg/dl in men and &lt;50 mg/dl in women).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>Age and sex adjusted control subjects</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for elective percutaneous coronary intervention Patients with metabolic&#xD;
        syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must be scheduled for elective percutaneous coronary intervention Clinical&#xD;
        diagnosis of metabolic syndrome Patients must give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Acute coronary events Acute renal failure End stage renal failure requiring hemodialysis&#xD;
        Contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous&#xD;
        coronary intervention Exposure to contrast agent within 1 week before the procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozgur Ulas Ozcan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara University School Of Medicine, Department of Cardiology</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>Özgür Ulaş Özcan</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>creatinine</keyword>
  <keyword>glomerular filtration rate</keyword>
  <keyword>metabolic syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02192372
org study id: MetS CIN
nct id: NCT02192372
lead sponsor: 
has dmc: No
Prevention of contrast induced nephropathy after interventional cardiologic procedures
      deserves close interest because of its association with prolonged hospitalization, increased
      cost and increased in hospital and long term mortality rates. An observational prospective
      cohort study was designed to determine whether metabolic syndrome predicts the development of
      contrast induced nephropathy after elective percutaneous coronary intervention.
observational model: Cohort
time perspective: Prospective
measure: Contrast induced nephropathy
time frame: 24-48 hours after the percutaneous coronary intervention
description: Contrast induced nephropathy was defined as an increase in serum creatinine of >25% or >0.5 mg/dl above the baseline value 24 or 48 hours after angiography.
measure: glomerular filtration rate
time frame: 48 hours after the percutaneous coronary intervention
description: Glomerular filtration rate was estimated using the Cockcroft-Gault formula: (140-age) x weight (kg)/ serum creatinine (mg/dl) x 72 (x 0.85 for females)
measure: Cut-off point for baseline glomerular filtration rate to predict development of contrast induced nephropathy
time frame: baseline glomerular filtration rate
arm group label: metabolic syndrome
description: Presence of 3 or more of these components: high fasting glucose (fasting serum glucose ≥ 100 mg/dl or drug treatment for elevated blood glucose), abdominal obesity (given as waist circumference > 102 cm in men and > 88 cm in women), high blood pressure (≥130/≥85 mmHg or drug treatment for hypertension), hypertriglyceridemia (serum triglycerides ≥150 mg/dl), low high-density lipoprotein cholesterol (<40 mg/dl in men and <50 mg/dl in women).
arm group label: control
description: Age and sex adjusted control subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ozgur Ulas Ozcan
role: Principal Investigator
affiliation: Ankara University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: Özgür Ulaş Özcan
investigator title: MD
mesh term: Kidney Diseases
mesh term: Metabolic Syndrome
mesh term: Syndrome