<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/NCT03269708</url>
  </required_header>
  <id_info>
    <org_study_id>109209</org_study_id>
    <nct_id>NCT03269708</nct_id>
  </id_info>
  <brief_title>Improving Cardiac Secondary Prevention</brief_title>
  <official_title>Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</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>
      The purpose of this study is to determine whether providing individuals with personalized&#xD;
      information on cellular aging, including telomere dynamics, will stimulate them to adhere to&#xD;
      cardiac prevention strategies and improve exercise capacity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise capacity based on cardiopulmonary exercise testing</measure>
    <time_frame>after 6-month cardiac rehabilitation program</time_frame>
    <description>Online VO2 maximum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to supervised exercise sessions</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of prescribed supervised on-site exercise sessions attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity assessment</measure>
    <time_frame>6 months</time_frame>
    <description>Garmin recording</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Secondary Prevention</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive standard care in cardiac rehabilitation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knowledge transfer group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive standard care in cardiac rehabilitation program plus education regarding telomere length</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education regarding telomere length</intervention_name>
    <description>Teaching concepts of cellular aging and telomere length</description>
    <arm_group_label>Knowledge transfer group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Individuals who have sustained a myocardial infarction and entered the cardiac&#xD;
        rehabilitation program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with genetic mutations that affect telomere length&#xD;
&#xD;
          2. Individuals who may not have the mental capacity to understanding the ramifications of&#xD;
             risk biomarkers&#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>J. Geoffrey Pickering, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>J. Geoffrey Pickering, MD PhD</last_name>
    <phone>519-663-3973</phone>
    <phone_ext>33973</phone_ext>
    <email>gpickering@robarts.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tim Hartley, MSc</last_name>
    <phone>(519) 646-6100</phone>
    <phone_ext>x36570</phone_ext>
    <email>tim.hartley@lhsc.on.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>London Health Sciences Centre, Western University</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Geoffrey Pickering MD PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <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/NCT03269708
org study id: 109209
nct id: NCT03269708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether providing individuals with personalized
      information on cellular aging, including telomere dynamics, will stimulate them to adhere to
      cardiac prevention strategies and improve exercise capacity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Exercise capacity based on cardiopulmonary exercise testing
time frame: after 6-month cardiac rehabilitation program
description: Online VO2 maximum
measure: Adherence to supervised exercise sessions
time frame: 6 months
description: Proportion of prescribed supervised on-site exercise sessions attended
measure: Activity assessment
time frame: 6 months
description: Garmin recording
arm group label: Control
arm group type: No Intervention
description: Participants receive standard care in cardiac rehabilitation program
arm group label: Knowledge transfer group
arm group type: Experimental
description: Participants receive standard care in cardiac rehabilitation program plus education regarding telomere length
intervention type: Behavioral
intervention name: Education regarding telomere length
description: Teaching concepts of cellular aging and telomere length
arm group label: Knowledge transfer group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: J. Geoffrey Pickering, MD PhD
role: Principal Investigator
affiliation: Western Faculty
last name: J. Geoffrey Pickering, MD PhD
phone: 519-663-3973
phone ext: 33973
email: gpickering@robarts.ca
last name: Tim Hartley, MSc
phone: (519) 646-6100
phone ext: x36570
email: tim.hartley@lhsc.on.ca
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Geoffrey Pickering MD PhD
investigator title: Professor
mesh term: Neoplasm Metastasis
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No