<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/NCT02220582</url>
  </required_header>
  <id_info>
    <org_study_id>CAHHM</org_study_id>
    <nct_id>NCT02220582</nct_id>
  </id_info>
  <brief_title>Canadian Alliance for Healthy Hearts and Minds</brief_title>
  <official_title>A Pan-Canadian, Multi-ethnic Cohort Study in Healthy Participants Aimed to Better Understand the Impact of Individual, Socioeconomic and Other Environmental Factors Leading to Cardiac and Vascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montreal Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective,&#xD;
      multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at&#xD;
      contextual risk factors and novel predictors of hard events over a period of four years.&#xD;
&#xD;
      The unique features of this initiative are:&#xD;
&#xD;
        -  MRI as the sole imaging technique (including the use of a mobile MRI machine)&#xD;
&#xD;
        -  Contextual factor analysis (including community environmental profile assessments)&#xD;
&#xD;
        -  Record linkage follow-up of individuals to health services (administrative) databases&#xD;
           for major morbidity and mortality events and health services utilization&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac, vascular, and cognitive dysfunction have a strong impact on the quality of life,&#xD;
      longevity and health care costs, in Canada and globally. Cardiovascular risk factors account&#xD;
      for up to half of the attributable risk for dementia, mediated in large part by difficult to&#xD;
      detect microvascular disease of the brain. In this study the investigators will try to&#xD;
      understand the role of the societal structure, nutrition, access to health services, and&#xD;
      other socio-environmental and contextual factors on cardiovascular risk factors, subclinical&#xD;
      disease and clinical cardiovascular events at the individual and population levels. We will&#xD;
      try to identify markers for early subclinical dysfunction in the brain, vessels, heart and&#xD;
      abdomen using magnetic resonance imaging and investigate the associations with contextual and&#xD;
      individual determinants of these markers, as well as to assess the predictive value of novel&#xD;
      markers of subclinical dysfunction on the development of clinical cardiovascular events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Myocardial Infarction (MI)</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percutaneous Transluminal Coronary Angioplasty</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percutaneous Coronary Intervention</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Coronary Artery Bypass Graft</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Congestive Heart Failure</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
    <description>Congestive Heart Failure requiring hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset established risk factors</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
    <description>Incident diagnosis of diabetes by physician&#xD;
Incident diagnosis of arterial hypertension by physician&#xD;
Incident diagnosis of significant cognitive dysfunction (i.e. dementia) by physician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk markers acquired through imaging and blood samples</measure>
    <time_frame>After completion of MRI and during follow-up period (2 to 3 years)</time_frame>
    <description>Acquired parameters that are linked to the present health status&#xD;
Candidate parameters for predicting cardiovascular events which affect cardiac and cognitive dysfunction. For further details, please see list of outcomes in the questionnaires and the MRI protocol described in section 4 above</description>
  </secondary_outcome>
  <enrollment type="Actual">7900</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Magnetic Resonance Imaging</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The study will precisely phenotype individuals with respect to cardiac, vascular and&#xD;
      cognitive dysfunction and to identify novel targets for indicators of early disease.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants of Canadian Partnership for Tomorrow Project (CPTP) cohorts (BC Generations,&#xD;
        Alberta Tomorrow Project, Ontario Health Study, CARTaGENE, Atlantic PATH) or non--CPTP&#xD;
        cohorts (Montreal Heart Institute Biobank or the Prospective Urban-Rural Epidemiology, PURE&#xD;
        study, or aboriginal cohort participants).&#xD;
&#xD;
        Multi-ethnic participants including reserve-based Aboriginal peoples.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Form (ICF) was discussed, understood and signed by the participant&#xD;
&#xD;
          -  Participant is between ages 35 and 69 (inclusively) at time of screening&#xD;
&#xD;
          -  The participant is willing to undergo an MRI scan and all other required study&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a known acute disease or condition that is considered serious in the&#xD;
             investigator's opinion&#xD;
&#xD;
          -  Participant is claustrophobic and/or is known to suffer from moderate to severe&#xD;
             anxiety during MRI scans or similar procedures&#xD;
&#xD;
          -  Participant is obese and/or exceeds equipment weight limit and/or circumference of the&#xD;
             MRI portal at this of screening&#xD;
&#xD;
          -  Participant has any kind of metallic device that would contra-indicate Magnetic&#xD;
             Resonance Imaging (MRI) (e.g. pacemakers, defibrillator, vascular clips, drug pumps,&#xD;
             implant(s), or any other foreign bodies)&#xD;
&#xD;
          -  Participant has an extensive tattoo covering a large part of their chest or head&#xD;
&#xD;
          -  Female participants that are currently pregnant (confirmed or uncertain).&#xD;
&#xD;
          -  Participants receiving Gadovist® only - Female participants that are currently&#xD;
             breastfeeding.&#xD;
&#xD;
          -  Participants receiving Gadovist® only - Participant has a known hypersensitivity to&#xD;
             gadolinium-based contrast agents&#xD;
&#xD;
          -  Participants receiving Gadovist® only - Participant has a known allergy or severe&#xD;
             reaction to any contrast agent typically used in MRI procedures&#xD;
&#xD;
          -  Participants receiving Gadovist® only - Participant has known renal or hepatic&#xD;
             impairment of any intensity or any other kidney/liver disease or has recently&#xD;
             undergone kidney/liver transplant&#xD;
&#xD;
          -  Participants receiving Gadovist® only - Participant has a known glomerular filtration&#xD;
             rate (eGFR or GFR) of 30 mL/min or less&#xD;
&#xD;
          -  Participants receiving Gadovist® only - Participant has taken part in a clinical&#xD;
             research study or clinical study within 30 days prior to enrollment in this study,&#xD;
             and/or received contrast agent within 72 hours prior to the study MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Friedrich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sonia Anand, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jack Tu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Clinical Evaluative Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seaman Family MR Research Center</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N4N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII Health Sciences Center</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robarts Research Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Insitute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Center</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IUCPQ</name>
      <address>
        <city>Ste Foy</city>
        <state>Quebec</state>
        <zip>G1V4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Magnetic Resonance (CMR)</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>socio-environmental factors</keyword>
  <keyword>Contextual factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02220582
org study id: CAHHM
nct id: NCT02220582
lead sponsor: 
has dmc: No
The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective,
      multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at
      contextual risk factors and novel predictors of hard events over a period of four years.

      The unique features of this initiative are:

        -  MRI as the sole imaging technique (including the use of a mobile MRI machine)

        -  Contextual factor analysis (including community environmental profile assessments)

        -  Record linkage follow-up of individuals to health services (administrative) databases
           for major morbidity and mortality events and health services utilization
Cardiac, vascular, and cognitive dysfunction have a strong impact on the quality of life,
      longevity and health care costs, in Canada and globally. Cardiovascular risk factors account
      for up to half of the attributable risk for dementia, mediated in large part by difficult to
      detect microvascular disease of the brain. In this study the investigators will try to
      understand the role of the societal structure, nutrition, access to health services, and
      other socio-environmental and contextual factors on cardiovascular risk factors, subclinical
      disease and clinical cardiovascular events at the individual and population levels. We will
      try to identify markers for early subclinical dysfunction in the brain, vessels, heart and
      abdomen using magnetic resonance imaging and investigate the associations with contextual and
      individual determinants of these markers, as well as to assess the predictive value of novel
      markers of subclinical dysfunction on the development of clinical cardiovascular events.
observational model: Cohort
time perspective: Prospective
measure: Myocardial Infarction (MI)
time frame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Stroke
time frame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Percutaneous Transluminal Coronary Angioplasty
time frame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Percutaneous Coronary Intervention
time frame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Coronary Artery Bypass Graft
time frame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Congestive Heart Failure
time frame: After completion of MRI and during follow-up period (2 to 3 years)
description: Congestive Heart Failure requiring hospitalization
measure: New onset established risk factors
time frame: After completion of MRI and during follow-up period (2 to 3 years)
description: Incident diagnosis of diabetes by physician
Incident diagnosis of arterial hypertension by physician
Incident diagnosis of significant cognitive dysfunction (i.e. dementia) by physician.
measure: Risk markers acquired through imaging and blood samples
time frame: After completion of MRI and during follow-up period (2 to 3 years)
description: Acquired parameters that are linked to the present health status
Candidate parameters for predicting cardiovascular events which affect cardiac and cognitive dysfunction. For further details, please see list of outcomes in the questionnaires and the MRI protocol described in section 4 above
intervention type: Other
intervention name: MRI
description: Magnetic Resonance Imaging
The study will precisely phenotype individuals with respect to cardiac, vascular and
      cognitive dysfunction and to identify novel targets for indicators of early disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Friedrich, MD
role: Principal Investigator
affiliation: Montreal Heart Institute
last name: Sonia Anand, PhD
role: Principal Investigator
affiliation: McMaster University
last name: Jack Tu, MD
role: Principal Investigator
affiliation: Institute for Clinical Evaluative Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Cardiovascular Diseases