<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/NCT01665365</url>
  </required_header>
  <id_info>
    <org_study_id>30685</org_study_id>
    <nct_id>NCT01665365</nct_id>
  </id_info>
  <brief_title>Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study</brief_title>
  <official_title>Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective follow-up study is to investigate 5-year clinical outcome in&#xD;
      patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning&#xD;
      before primary percutaneous coronary intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2007</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse cardiac and cerebrovascular events (MACCE)</measure>
    <time_frame>5 years</time_frame>
    <description>MACCE defined as all-cause mortality, readmission for heart failure, myocardial infarction, and ischemic stroke/transient ischemic attack. Data are collected from Danish nationwide registries and medical records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LV-function and remodeling</measure>
    <time_frame>5 years</time_frame>
    <description>LV-function and remodeling measured by echocardiography.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">251</enrollment>
  <condition>ST-elevation Myocardial Infarction (STEMI)</condition>
  <arm_group>
    <arm_group_label>1. Remote ischemic perconditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention (intervention group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary percutaneous coronary intervention (control group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote ischemic perconditioning</intervention_name>
    <description>Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention.</description>
    <arm_group_label>1. Remote ischemic perconditioning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chest pain before admission to hospital within 12 h of onset, ST-segment elevation of&#xD;
             &gt; 0,1 mV in 2 or more contiguous leads, 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  left bundle branch block, previous myocardial infarction, fibrinolytic treatment in&#xD;
             the previous 30 days, previous coronary bypass surgery, left main stem stenosis&#xD;
             requiring coronary bypass surgery, severe heart failure requiring mechanical&#xD;
             ventilation or use of an intra-aortic balloon pump.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Astrid D Sloth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiology, Aarhus University Hospital, Skejby</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>April 13, 2015</last_update_submitted>
  <last_update_submitted_qc>April 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial infarction</keyword>
  <keyword>Remote ischemic conditioning</keyword>
  <keyword>Clinical outcome</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/NCT01665365
org study id: 30685
nct id: NCT01665365
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The aim of this prospective follow-up study is to investigate 5-year clinical outcome in
      patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning
      before primary percutaneous coronary intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Major adverse cardiac and cerebrovascular events (MACCE)
time frame: 5 years
description: MACCE defined as all-cause mortality, readmission for heart failure, myocardial infarction, and ischemic stroke/transient ischemic attack. Data are collected from Danish nationwide registries and medical records.
measure: LV-function and remodeling
time frame: 5 years
description: LV-function and remodeling measured by echocardiography.
arm group label: 1. Remote ischemic perconditioning
arm group type: Experimental
description: Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention (intervention group).
arm group label: 2.
arm group type: No Intervention
description: Primary percutaneous coronary intervention (control group).
intervention type: Procedure
intervention name: Remote ischemic perconditioning
description: Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention.
arm group label: 1. Remote ischemic perconditioning
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Astrid D Sloth, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction