<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/NCT01676519</url>
  </required_header>
  <id_info>
    <org_study_id>Arezzo007</org_study_id>
    <nct_id>NCT01676519</nct_id>
  </id_info>
  <brief_title>Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale San Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale San Donato</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary&#xD;
      intervention (PCI) in whom development of critical limb ischemia was prospectively assessed&#xD;
      by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary&#xD;
      endpoint of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2002</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">May 2007</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>cardiac mortality rate</measure>
    <time_frame>4-year follow-up</time_frame>
    <description>incidence of cardiac death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>major adverse cardiac event rate</measure>
    <time_frame>4-year follow-up</time_frame>
    <description>incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">764</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>PCI</arm_group_label>
    <description>diabetic patients undergoing percutaneous coronary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCI</intervention_name>
    <description>percutaneous coronary intervention</description>
    <arm_group_label>PCI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive diabetic patients undergoing percutaneous coronary intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  need for coronary revascularization&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical contraindications to prolonged double antiplatelet therapy&#xD;
&#xD;
          -  life expectancy &lt; 1 year&#xD;
&#xD;
          -  lack of consent&#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>Cardiovascular Department, Ospedale S.Donato</name>
      <address>
        <city>Arezzo</city>
        <state>AR</state>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale San Donato</investigator_affiliation>
    <investigator_full_name>Leonardo Bolognese, MD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT01676519
org study id: Arezzo007
nct id: NCT01676519
lead sponsor: 
has dmc: No
Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary
      intervention (PCI) in whom development of critical limb ischemia was prospectively assessed
      by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary
      endpoint of the study.
observational model: Cohort
time perspective: Prospective
measure: cardiac mortality rate
time frame: 4-year follow-up
description: incidence of cardiac death
measure: major adverse cardiac event rate
time frame: 4-year follow-up
description: incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization)
arm group label: PCI
description: diabetic patients undergoing percutaneous coronary intervention
intervention type: Procedure
intervention name: PCI
description: percutaneous coronary intervention
arm group label: PCI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Ospedale San Donato
investigator full name: Leonardo Bolognese, MD
investigator title: Director
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia