<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/NCT02197117</url>
  </required_header>
  <id_info>
    <org_study_id>ERIC-LYSIS</org_study_id>
    <nct_id>NCT02197117</nct_id>
  </id_info>
  <brief_title>Effect of Remote Ischemic Conditioning in Heart Attack Patients</brief_title>
  <acronym>ERIC-LYSIS</acronym>
  <official_title>Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      New treatments are required to improve health outcomes in patients with ischemic heart&#xD;
      disease. This is especially so in developing countries such as Mauritius in which optimal&#xD;
      therapy for acute myocardial infarction may not be widely available. For example for patients&#xD;
      presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the&#xD;
      treatment of choice would be to remove the blockage by primary percutaneous coronary&#xD;
      intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to&#xD;
      keep the artery opened. However, PCI is not widely available in Mauritius and heart attack&#xD;
      patients are given clot-busting therapy to remove the blockage, but this is not as effective&#xD;
      as PCI.&#xD;
&#xD;
      Therefore, in this research study we investigate a new cheap treatment that may help protect&#xD;
      the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in&#xD;
      which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated&#xD;
      for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart&#xD;
      attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff&#xD;
      a protective signal can be relayed to the heart to reduce the amount of damage occurring&#xD;
      during the heart attack and thereby prevent the onset of heart failure.&#xD;
&#xD;
      Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to&#xD;
      the heart muscle during a heart attack..&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Myocardial infarct size</measure>
    <time_frame>Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis</time_frame>
    <description>Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>Measured by serum creatinine at 24 hours</time_frame>
    <description>Measured by serum creatinine at 24 hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">519</enrollment>
  <condition>ST-segment Elevation Myocardial Infarction (STEMI)</condition>
  <arm_group>
    <arm_group_label>Remote ischemic conditioning</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard blood pressure cuff placed on upper arm and inflated to 200 mmHg. The cuff is left inflated at this level for 5 minutes and then rapidly deflated to 0 mmHg left deflated for 5 minutes0 this cycle is repeated 4 times in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote ischemic conditioning</intervention_name>
    <arm_group_label>Remote ischemic conditioning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Presentation within 12 hours of onset of chest pain&#xD;
&#xD;
          -  ECG showing ST-segment elevation of ≥0.1mV in two contiguous leads (≥0.2mV in leads&#xD;
             V1-V3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -None -&#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>Victoria Hospital</name>
      <address>
        <city>Candos</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flacq Hospital</name>
      <address>
        <city>Flacq</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Seewoosagur Ramgoolam National Hospital</name>
      <address>
        <city>Pamplemousses</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr AG Jeetoo Hospital</name>
      <address>
        <city>Port Louis</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jawaharlal Nehru Hospital</name>
      <address>
        <city>Rose-Belle</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mauritius</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>May 7, 2017</last_update_submitted>
  <last_update_submitted_qc>May 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College, London</investigator_affiliation>
    <investigator_full_name>Derek Hausenloy</investigator_full_name>
    <investigator_title>Professor in Cardiovascular Medicine</investigator_title>
  </responsible_party>
  <keyword>ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection</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/NCT02197117
org study id: ERIC-LYSIS
nct id: NCT02197117
lead sponsor: 
has dmc: Yes
New treatments are required to improve health outcomes in patients with ischemic heart
      disease. This is especially so in developing countries such as Mauritius in which optimal
      therapy for acute myocardial infarction may not be widely available. For example for patients
      presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the
      treatment of choice would be to remove the blockage by primary percutaneous coronary
      intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to
      keep the artery opened. However, PCI is not widely available in Mauritius and heart attack
      patients are given clot-busting therapy to remove the blockage, but this is not as effective
      as PCI.

      Therefore, in this research study we investigate a new cheap treatment that may help protect
      the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in
      which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated
      for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart
      attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff
      a protective signal can be relayed to the heart to reduce the amount of damage occurring
      during the heart attack and thereby prevent the onset of heart failure.

      Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to
      the heart muscle during a heart attack..
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Myocardial infarct size
time frame: Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis
description: Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis.
measure: Acute kidney injury
time frame: Measured by serum creatinine at 24 hours
description: Measured by serum creatinine at 24 hours.
arm group label: Remote ischemic conditioning
arm group type: Active Comparator
description: Standard blood pressure cuff placed on upper arm and inflated to 200 mmHg. The cuff is left inflated at this level for 5 minutes and then rapidly deflated to 0 mmHg left deflated for 5 minutes0 this cycle is repeated 4 times in total.
arm group label: Control
arm group type: Sham Comparator
description: Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.
intervention type: Device
intervention name: Remote ischemic conditioning
arm group label: Remote ischemic conditioning
intervention type: Device
intervention name: Control
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Mauritius
responsible party type: Principal Investigator
investigator affiliation: University College, London
investigator full name: Derek Hausenloy
investigator title: Professor in Cardiovascular Medicine
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction