<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/NCT01664611</url>
  </required_header>
  <id_info>
    <org_study_id>0306</org_study_id>
    <nct_id>NCT01664611</nct_id>
  </id_info>
  <brief_title>Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction</brief_title>
  <acronym>DREAM</acronym>
  <official_title>The DREAM Study (Daily Remote Ischaemic Conditioning Following Acute Myocardial Infarction)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Freemasons' Medical Research Funding</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leicester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the&#xD;
      peri/immediate post infarct period. However little is known as to the effect of repeated&#xD;
      remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on&#xD;
      ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial,&#xD;
      the investigators intend to carry out daily remote ischaemic conditioning in post MI&#xD;
      patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following&#xD;
      a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic&#xD;
      resonance imaging.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2012</start_date>
  <completion_date type="Actual">October 30, 2016</completion_date>
  <primary_completion_date type="Actual">October 30, 2016</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in LVEF from baseline to 4 months as assessed by cMRI</measure>
    <time_frame>Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI.</time_frame>
    <description>Mean change in LVEF from baseline to 4 months as assessed by cMRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Final infarct size at 4 months as assessed by cMRI</measure>
    <time_frame>Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.</time_frame>
    <description>Final infarct size at 4 months as assessed by cMRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months</measure>
    <time_frame>Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI.</time_frame>
    <description>Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean KCCQ score at 4 months</measure>
    <time_frame>Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.</time_frame>
    <description>Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Post Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm</intervention_name>
    <description>Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.</description>
    <arm_group_label>Treatment arm</arm_group_label>
    <other_name>The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300.</other_name>
    <other_name>Cell Aegis AutoRIC machine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham conditioning</intervention_name>
    <description>Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury</description>
    <arm_group_label>Sham arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LVEF &lt; 45% on baseline ECHO&#xD;
&#xD;
          -  First STEMI&#xD;
&#xD;
          -  Successful revascularisation by PPCI&#xD;
&#xD;
          -  Able to attend regional centre for follow-up appointment&#xD;
&#xD;
          -  Competent to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 of age&#xD;
&#xD;
          -  ICD or CRTP/D in-situ&#xD;
&#xD;
          -  Prior history of heart failure&#xD;
&#xD;
          -  Haemoglobin &lt; 11.5 g/dl&#xD;
&#xD;
          -  Creatinine &gt; 200 µmol/L (eGFR&lt;30ml/min/m2)&#xD;
&#xD;
          -  Known malignancy/other comorbid condition which in the opinion of the investigator is&#xD;
             likely to have significant negative influence on life expectancy&#xD;
&#xD;
          -  Significant complications/illness following MI&#xD;
&#xD;
          -  Unable to undergo cMRI&#xD;
&#xD;
          -  Further planned coronary interventions&#xD;
&#xD;
          -  Enrollment in another clinical trial&#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>Nilesh Samani, FRCP, MD, MBChB, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leicester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univesrity of Leicester, Department of Cardiovascular Science</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Remote Ischaemic Conditioning</keyword>
  <keyword>Remodeling</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Ischaemia/Reperfusion Injury</keyword>
  <keyword>successful primary percutaneous coronary intervention following a first STEMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01664611
org study id: 0306
nct id: NCT01664611
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the
      peri/immediate post infarct period. However little is known as to the effect of repeated
      remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on
      ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial,
      the investigators intend to carry out daily remote ischaemic conditioning in post MI
      patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following
      a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic
      resonance imaging.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Mean change in LVEF from baseline to 4 months as assessed by cMRI
time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Primary outcome measure assessed at baseline and 4 months post MI.
description: Mean change in LVEF from baseline to 4 months as assessed by cMRI
measure: Final infarct size at 4 months as assessed by cMRI
time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.
description: Final infarct size at 4 months as assessed by cMRI
measure: Mean blood biomarker levels of heart failure and ventricular remodelling at baseline and 4 months
time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at baseline and 4 months post MI.
description: Mean blood biomarker levels of heart failure and ventricular remodelling (e.g. NT-proBNP, MMP9, TIMP1) at baseline and 4 months
measure: Mean KCCQ score at 4 months
time frame: Participants will be followed for a total of 4 months from date of MI to final outpatient follow-up at which point they will be discharged. Secondary outcome measure assessed at 4 months post MI.
description: Mean Kansas City Cardiomyopathy Screen (KCCQ) score at 4 months
arm group label: Treatment arm
arm group type: Experimental
description: Participants in this arm will receive remote ischaemic conditioning on a daily basis for 4 weeks post MI
arm group label: Sham arm
arm group type: Sham Comparator
description: Participants in this arm will receive sham ischaemic conditioning on a daily basis for 4 weeks post MI
intervention type: Procedure
intervention name: Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm
description: Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
arm group label: Treatment arm
other name: The electronic blood pressure cuff used to induce conditioning is the Accoson Greenlight 300.
other name: Cell Aegis AutoRIC machine
intervention type: Procedure
intervention name: Sham conditioning
description: Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
arm group label: Sham arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nilesh Samani, FRCP, MD, MBChB, BSc
role: Principal Investigator
affiliation: University of Leicester
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No