<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/NCT01705665</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-70-10</org_study_id>
    <nct_id>NCT01705665</nct_id>
  </id_info>
  <brief_title>Histopathology of the Aspirated Thrombus During Acute Myocardial Infarction</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was initiated on the preliminary premise that a thrombus whose formation was&#xD;
      triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue&#xD;
      factor initiated thrombus), may evolve differently than the one evolving at the site of a&#xD;
      recently implanted stent (foreign body triggered). Consequently, the thrombus composition of&#xD;
      a de novo clot could differ from the other one, extracted during the occurrence of a subacute&#xD;
      thrombosis, regarding the number of various cells, the amount of fibrin and platelet&#xD;
      aggregates and the relationship among these components. In addition, it seems relevant to&#xD;
      evaluate the numbers and the distribution of the local monocytes, once these cells may&#xD;
      interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the&#xD;
      extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a&#xD;
      distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary&#xD;
      arteries, and may have clinical implications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis</measure>
    <time_frame>two years</time_frame>
    <description>Analysis of thrombotic specimen contents aspirated during Acute Myocardial Infarction by searching for possible differences in the components of the thrombotic debris, whether cellular, or fibrin and platelets, in accordance with clinical parameters.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Thrombosis</condition>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Aspirated Coronary Thrombi During AMI</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted for an acute coronary syndrome who undergo angiography, found to have a&#xD;
        coronary thrombosis that is aspirated and which yields thrombus fragments.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute coronary syndrome who undergo angiography&#xD;
&#xD;
          -  Evidence of coronary thrombus&#xD;
&#xD;
          -  Undergo aspiration procedure yielding thrombus fragments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Heart Institute, Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simcha R Meisel, MD, MSc</last_name>
      <phone>972-4-6304470</phone>
      <email>meisel@hy.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Simcha R Meisel, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mary Amar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edmond Sabo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Acute Coronary 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/NCT01705665
org study id: HYMC-70-10
nct id: NCT01705665
lead sponsor: 
has dmc: No
This study was initiated on the preliminary premise that a thrombus whose formation was
      triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue
      factor initiated thrombus), may evolve differently than the one evolving at the site of a
      recently implanted stent (foreign body triggered). Consequently, the thrombus composition of
      a de novo clot could differ from the other one, extracted during the occurrence of a subacute
      thrombosis, regarding the number of various cells, the amount of fibrin and platelet
      aggregates and the relationship among these components. In addition, it seems relevant to
      evaluate the numbers and the distribution of the local monocytes, once these cells may
      interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the
      extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a
      distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary
      arteries, and may have clinical implications.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis
time frame: two years
description: Analysis of thrombotic specimen contents aspirated during Acute Myocardial Infarction by searching for possible differences in the components of the thrombotic debris, whether cellular, or fibrin and platelets, in accordance with clinical parameters.
arm group label: Aspirated Coronary Thrombi During AMI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Acute Coronary Syndrome