<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/NCT03267199</url>
  </required_header>
  <id_info>
    <org_study_id>17100302</org_study_id>
    <nct_id>NCT03267199</nct_id>
  </id_info>
  <brief_title>The Relationship Between MPV,PDW,PFT and ST Segment Resolution in STEMI Patients Treated With Thrombolytic or Primary PCI</brief_title>
  <official_title>The Relationship Between Mean Platelet Volume , Platelet Distribution Width , Platelet Function and ST Segment Resolution in STEMI Patients Treated With Either Thrombolytic Therapy or Primary Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  The relationship between admission MPV, PDW, platelet function test and ST-segment&#xD;
           resolution in STEMI patients treated with either thrombolytic therapy or primary&#xD;
           percutaneous coronary intervention&#xD;
&#xD;
        -  The relationship between admission MPV, PDW, platelet function test and high thrombus&#xD;
           burden &amp; post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related&#xD;
           artery in STEMI patients treated with primary percutaneous coronary intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reperfusion therapy as the main treatment strategy in patients with ST-segment elevation&#xD;
      myocardial infarction (STEMI) consists of either thrombolysis or primary percutaneous&#xD;
      coronary intervention (pPCI). Primary percutaneous coronary intervention is the preferred&#xD;
      therapy for STEMI; however, cardiac catheterization laboratories may not be widely available.&#xD;
&#xD;
      Early recanalization of the infarct related artery (IRA) by either thrombolytics or&#xD;
      percutaneous coronary intervention (PCI) is the main goal in the treatment of acute&#xD;
      myocardial infarction. But the eventual aim is to provide reperfusion at the tissue level as&#xD;
      well as in the infarct related artery .&#xD;
&#xD;
      Resolution of ST elevation has been shown as an agreeable marker that reflects both&#xD;
      epicardial and myocardial reperfusion . In addition, early and complete resolution of ST&#xD;
      -segment in the setting of acute myocardial infarction is associated with smaller infarct&#xD;
      size, greater ejection fraction and reduced morbidity and mortality .&#xD;
&#xD;
      Platelets play a critical role in the pathogenesis and prognosis of ACS . They secrete a&#xD;
      number of substances that are key mediators of coagulation, thrombosis and atherosclerosis.&#xD;
      High-volume platelets have a higher thrombotic potential than small platelets and have&#xD;
      concentrated granule contents that are of interest in the development of ACS pathogenesis .&#xD;
      Mean platelet volume (MPV) is the most commonly used measure of platelet size and correlates&#xD;
      with platelet activity. Platelet distribution width (PDW) is an index reflecting&#xD;
      heterogeneous platelet size, whereas the platelet-large cell ratio (P-LCR) is the proportion&#xD;
      of large platelets in blood circulation. Generally, higher MPV, PDW and P-LCR are correlated&#xD;
      with increased platelet size, although they tend to be overlooked in clinical applications.&#xD;
      In fact, these indices, particularly MPV and PDW, correlate with platelet functions.&#xD;
&#xD;
      Percutaneous coronary intervention (PCI) is an effective treatment for acute coronary&#xD;
      syndrome (ACS), including ST-elevation myocardial infarction (STEMI) and unstable angina.&#xD;
      Despite the efficacy of the technique, preprocedural high-thrombus burden (HTB) is a&#xD;
      predictor of procedural complications following primary PCI for STEMI. HTB can lead to poor&#xD;
      outcomes, including distal embolization, no-reflow, increased myocardial necrosis and&#xD;
      decreased left ventricular function.&#xD;
&#xD;
      Although MPV is associated with impaired angiographic reperfusion and poor clinical outcome&#xD;
      in patients with STEMI,little is known regarding the association between MPV levels and&#xD;
      infarct related artery patency in those patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Another study was done instead&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients assessed by CBC ,platelet function test &amp; ECG</measure>
    <time_frame>Baseline and 90 min after either the beginning treatment with thrombolytic therapy or primary PCI</time_frame>
    <description>Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention assessed by CBC,platelet function test &amp; ECG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between MPV,PDW,platelet function test and TIMI flow of infarct related artery in STEMI patients treated with primary PCI</measure>
    <time_frame>Baseline</time_frame>
    <description>Correlation between MPV ,PDW,platelet function test and post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between MPV,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary PCI</measure>
    <time_frame>Baseline</time_frame>
    <description>Correlation between MPV ,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>patients with high MPV,PDW,PFT</arm_group_label>
    <description>patients with high MPV,PDW,platelet function test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with normal or low MPV,PDW, PFT</arm_group_label>
    <description>patients with normal or low MPV,PDW,platelet function test</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thrombolytic</intervention_name>
    <description>Thrombolytic therapy</description>
    <arm_group_label>patients with high MPV,PDW,PFT</arm_group_label>
    <arm_group_label>patients with normal or low MPV,PDW, PFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Primary PCI</intervention_name>
    <description>Primary percutaneous coronary intervention</description>
    <arm_group_label>patients with high MPV,PDW,PFT</arm_group_label>
    <arm_group_label>patients with normal or low MPV,PDW, PFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Complete blood count</intervention_name>
    <description>Blood sample for complete blood count</description>
    <arm_group_label>patients with high MPV,PDW,PFT</arm_group_label>
    <arm_group_label>patients with normal or low MPV,PDW, PFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Platelet function test</intervention_name>
    <description>Blood sample for platelet function test</description>
    <arm_group_label>patients with high MPV,PDW,PFT</arm_group_label>
    <arm_group_label>patients with normal or low MPV,PDW, PFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ECG</intervention_name>
    <description>Electrocardiogram</description>
    <arm_group_label>patients with high MPV,PDW,PFT</arm_group_label>
    <arm_group_label>patients with normal or low MPV,PDW, PFT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with STEMI presented who will be treated with either thrombolytic therapy or&#xD;
        primary PCI in assiut university cath lab will be included in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with STEMI presented who will be treated with either thrombolytic therapy or&#xD;
             primary PCI in assiut university cath lab will be included in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with complete LBBB on admission ECG&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Documented systemic inflammatory disease&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  End-stage liver&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Patient receiving oral anticoagulation medicine&#xD;
&#xD;
          -  Bleeding diathesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Nardeen Beshay</investigator_full_name>
    <investigator_title>resident physician</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrinolytic Agents</mesh_term>
  </intervention_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/NCT03267199
org study id: 17100302
nct id: NCT03267199
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  The relationship between admission MPV, PDW, platelet function test and ST-segment
           resolution in STEMI patients treated with either thrombolytic therapy or primary
           percutaneous coronary intervention

        -  The relationship between admission MPV, PDW, platelet function test and high thrombus
           burden & post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related
           artery in STEMI patients treated with primary percutaneous coronary intervention
Reperfusion therapy as the main treatment strategy in patients with ST-segment elevation
      myocardial infarction (STEMI) consists of either thrombolysis or primary percutaneous
      coronary intervention (pPCI). Primary percutaneous coronary intervention is the preferred
      therapy for STEMI; however, cardiac catheterization laboratories may not be widely available.

      Early recanalization of the infarct related artery (IRA) by either thrombolytics or
      percutaneous coronary intervention (PCI) is the main goal in the treatment of acute
      myocardial infarction. But the eventual aim is to provide reperfusion at the tissue level as
      well as in the infarct related artery .

      Resolution of ST elevation has been shown as an agreeable marker that reflects both
      epicardial and myocardial reperfusion . In addition, early and complete resolution of ST
      -segment in the setting of acute myocardial infarction is associated with smaller infarct
      size, greater ejection fraction and reduced morbidity and mortality .

      Platelets play a critical role in the pathogenesis and prognosis of ACS . They secrete a
      number of substances that are key mediators of coagulation, thrombosis and atherosclerosis.
      High-volume platelets have a higher thrombotic potential than small platelets and have
      concentrated granule contents that are of interest in the development of ACS pathogenesis .
      Mean platelet volume (MPV) is the most commonly used measure of platelet size and correlates
      with platelet activity. Platelet distribution width (PDW) is an index reflecting
      heterogeneous platelet size, whereas the platelet-large cell ratio (P-LCR) is the proportion
      of large platelets in blood circulation. Generally, higher MPV, PDW and P-LCR are correlated
      with increased platelet size, although they tend to be overlooked in clinical applications.
      In fact, these indices, particularly MPV and PDW, correlate with platelet functions.

      Percutaneous coronary intervention (PCI) is an effective treatment for acute coronary
      syndrome (ACS), including ST-elevation myocardial infarction (STEMI) and unstable angina.
      Despite the efficacy of the technique, preprocedural high-thrombus burden (HTB) is a
      predictor of procedural complications following primary PCI for STEMI. HTB can lead to poor
      outcomes, including distal embolization, no-reflow, increased myocardial necrosis and
      decreased left ventricular function.

      Although MPV is associated with impaired angiographic reperfusion and poor clinical outcome
      in patients with STEMI,little is known regarding the association between MPV levels and
      infarct related artery patency in those patients.
observational model: Cohort
time perspective: Prospective
measure: Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients assessed by CBC ,platelet function test & ECG
time frame: Baseline and 90 min after either the beginning treatment with thrombolytic therapy or primary PCI
description: Correlation between admission MPV ,PDW ,platelet function test and change in ST-segment elevation in STEMI patients treated with either thrombolytic therapy or primary percutaneous coronary intervention assessed by CBC,platelet function test & ECG
measure: Correlation between MPV,PDW,platelet function test and TIMI flow of infarct related artery in STEMI patients treated with primary PCI
time frame: Baseline
description: Correlation between MPV ,PDW,platelet function test and post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
measure: Correlation between MPV,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary PCI
time frame: Baseline
description: Correlation between MPV ,PDW,platelet function test and high thrombus burden of infarct related artery in STEMI patients treated with primary percutaneous coronary intervention
arm group label: patients with high MPV,PDW,PFT
description: patients with high MPV,PDW,platelet function test
arm group label: patients with normal or low MPV,PDW, PFT
description: patients with normal or low MPV,PDW,platelet function test
intervention type: Drug
intervention name: Thrombolytic
description: Thrombolytic therapy
arm group label: patients with high MPV,PDW,PFT
arm group label: patients with normal or low MPV,PDW, PFT
intervention type: Procedure
intervention name: Primary PCI
description: Primary percutaneous coronary intervention
arm group label: patients with high MPV,PDW,PFT
arm group label: patients with normal or low MPV,PDW, PFT
intervention type: Diagnostic Test
intervention name: Complete blood count
description: Blood sample for complete blood count
arm group label: patients with high MPV,PDW,PFT
arm group label: patients with normal or low MPV,PDW, PFT
intervention type: Diagnostic Test
intervention name: Platelet function test
description: Blood sample for platelet function test
arm group label: patients with high MPV,PDW,PFT
arm group label: patients with normal or low MPV,PDW, PFT
intervention type: Diagnostic Test
intervention name: ECG
description: Electrocardiogram
arm group label: patients with high MPV,PDW,PFT
arm group label: patients with normal or low MPV,PDW, PFT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Nardeen Beshay
investigator title: resident physician
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Fibrinolytic Agents