<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/NCT01663194</url>
  </required_header>
  <id_info>
    <org_study_id>mgkaya-makpek</org_study_id>
    <nct_id>NCT01663194</nct_id>
  </id_info>
  <brief_title>Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction</brief_title>
  <official_title>Observational Study of N/L Ratio in Patients With STEMI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TC Erciyes University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with&#xD;
      adverse outcomes among patients with coronary artery disease, its role during the acute phase&#xD;
      of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This&#xD;
      study sought to investigate the association of the pre-procedural N/L ratio within-hospital&#xD;
      and long-term outcomes among STEMI patients undergoing primary percutaneous coronary&#xD;
      intervention (PCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inflammation plays a role in the initiation and progression of the atherosclerotic process.&#xD;
      Due to a growing recognition of its role, recent studies have focused on inflammatory markers&#xD;
      and their association with outcomes in patients with ST-segment elevation myocardial&#xD;
      infarction (STEMI). Recently, our single center study demonstrated that preprocedural&#xD;
      neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after&#xD;
      primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac&#xD;
      events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L&#xD;
      ratio in long-term outcomes among patients with STEMI; however, they evaluated the&#xD;
      association between long-term mortality and in-hospital N/L ratio, they were single-center&#xD;
      studies and they evaluated a relatively small study population.&#xD;
&#xD;
      In the present multicenter experience, the investigators aimed to investigate the association&#xD;
      of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with&#xD;
      STEMI undergoing primary PCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2000</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1034</enrollment>
  <condition>ST Elevated Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>N/L ratio tertile 2</arm_group_label>
    <description>patients were divided in to the tertiles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N/L ratio tertile 3</arm_group_label>
    <description>patients were divided in to the tertiles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N/L ratio tertile 1</arm_group_label>
    <description>patients were divided in to the tertiles</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>primary percutaneous coronary intervention, each groups</intervention_name>
    <description>All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).</description>
    <arm_group_label>N/L ratio tertile 1</arm_group_label>
    <arm_group_label>N/L ratio tertile 2</arm_group_label>
    <arm_group_label>N/L ratio tertile 3</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and plasma of blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        STEMI patients who were admitted within 6 hours from symptom onset and who underwent&#xD;
        primary PCI were prospectively included in this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ST elevated myocardial infarction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Treatment with fibrinolytic drugs in the previous 24 hours Active infection Previously&#xD;
        documented history of a systemic inflammatory process Known malignancy End-stage liver&#xD;
        disease Renal failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmut Akpek, MD</last_name>
    <role>Study Director</role>
    <affiliation>Erciyes University school of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erciyes University school of medicine</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 13, 2012</last_update_submitted>
  <last_update_submitted_qc>August 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TC Erciyes University</investigator_affiliation>
    <investigator_full_name>Mahmut Akpek</investigator_full_name>
    <investigator_title>Medical doctor of cardiology department</investigator_title>
  </responsible_party>
  <keyword>N/L ratio, STEMI, primary PCI, Long-term mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT01663194
org study id: mgkaya-makpek
nct id: NCT01663194
lead sponsor: 
has dmc: No
Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with
      adverse outcomes among patients with coronary artery disease, its role during the acute phase
      of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This
      study sought to investigate the association of the pre-procedural N/L ratio within-hospital
      and long-term outcomes among STEMI patients undergoing primary percutaneous coronary
      intervention (PCI).
Inflammation plays a role in the initiation and progression of the atherosclerotic process.
      Due to a growing recognition of its role, recent studies have focused on inflammatory markers
      and their association with outcomes in patients with ST-segment elevation myocardial
      infarction (STEMI). Recently, our single center study demonstrated that preprocedural
      neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after
      primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac
      events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L
      ratio in long-term outcomes among patients with STEMI; however, they evaluated the
      association between long-term mortality and in-hospital N/L ratio, they were single-center
      studies and they evaluated a relatively small study population.

      In the present multicenter experience, the investigators aimed to investigate the association
      of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with
      STEMI undergoing primary PCI.
observational model: Cohort
time perspective: Prospective
arm group label: N/L ratio tertile 2
description: patients were divided in to the tertiles
arm group label: N/L ratio tertile 3
description: patients were divided in to the tertiles
arm group label: N/L ratio tertile 1
description: patients were divided in to the tertiles
intervention type: Procedure
intervention name: primary percutaneous coronary intervention, each groups
description: All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).
arm group label: N/L ratio tertile 1
arm group label: N/L ratio tertile 2
arm group label: N/L ratio tertile 3
serum and plasma of blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mahmut Akpek, MD
role: Study Director
affiliation: Erciyes University school of medicine
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: TC Erciyes University
investigator full name: Mahmut Akpek
investigator title: Medical doctor of cardiology department
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction