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Canadian Alliance for Healthy Hearts and Minds

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ClinicalTrials.gov Identifier: NCT02220582
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute

Tracking Information
First Submitted Date August 18, 2014
First Posted Date August 20, 2014
Last Update Posted Date February 21, 2020
Actual Study Start Date November 2013
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2014)
  • Myocardial Infarction (MI) [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  • Stroke [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  • Percutaneous Transluminal Coronary Angioplasty [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  • Percutaneous Coronary Intervention [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  • Coronary Artery Bypass Graft [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
Original Primary Outcome Measures
 (submitted: August 19, 2014)
Miocardial Infarction (MI), Stroke, Percutaneous Transluminal Coronary Angioplasty(PTCA) or Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG), new diagnosis of cancer, Death [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
The primary outcomes include MI, Stroke, PTCA/PCI, CABG, new diagnosis of cancer, and Death.
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2014)
  • Congestive Heart Failure [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
    Congestive Heart Failure requiring hospitalization
  • New onset established risk factors [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
    • Incident diagnosis of diabetes by physician
    • Incident diagnosis of arterial hypertension by physician
    • Incident diagnosis of significant cognitive dysfunction (i.e. dementia) by physician.
  • Risk markers acquired through imaging and blood samples [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
    • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Canadian Alliance for Healthy Hearts and Minds
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
Brief Summary

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
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The study will precisely phenotype individuals with respect to cardiac, vascular and cognitive dysfunction and to identify novel targets for indicators of early disease.
Sampling Method Non-Probability Sample
Study Population

Participants of Canadian Partnership for Tomorrow Project (CPTP) cohorts (BC Generations, Alberta Tomorrow Project, Ontario Health Study, CARTaGENE, Atlantic PATH) or non--CPTP cohorts (Montreal Heart Institute Biobank or the Prospective Urban-Rural Epidemiology, PURE study, or aboriginal cohort participants).

Multi-ethnic participants including reserve-based Aboriginal peoples.

Condition Cardiovascular Diseases
Intervention Other: MRI
Magnetic Resonance Imaging
Study Groups/Cohorts Not Provided
Publications * Teixeira T, Hafyane T, Stikov N, Akdeniz C, Greiser A, Friedrich MG. Comparison of different cardiovascular magnetic resonance sequences for native myocardial T1 mapping at 3T. J Cardiovasc Magn Reson. 2016 Oct 4;18(1):65.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2017)
7900
Original Estimated Enrollment
 (submitted: August 19, 2014)
9700
Actual Study Completion Date April 2019
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Informed Consent Form (ICF) was discussed, understood and signed by the participant
  • Participant is between ages 35 and 69 (inclusively) at time of screening
  • The participant is willing to undergo an MRI scan and all other required study procedures

Exclusion Criteria:

  • Participant has a known acute disease or condition that is considered serious in the investigator's opinion
  • Participant is claustrophobic and/or is known to suffer from moderate to severe anxiety during MRI scans or similar procedures
  • Participant is obese and/or exceeds equipment weight limit and/or circumference of the MRI portal at this of screening
  • Participant has any kind of metallic device that would contra-indicate Magnetic Resonance Imaging (MRI) (e.g. pacemakers, defibrillator, vascular clips, drug pumps, implant(s), or any other foreign bodies)
  • Participant has an extensive tattoo covering a large part of their chest or head
  • Female participants that are currently pregnant (confirmed or uncertain).
  • Participants receiving Gadovist® only - Female participants that are currently breastfeeding.
  • Participants receiving Gadovist® only - Participant has a known hypersensitivity to gadolinium-based contrast agents
  • Participants receiving Gadovist® only - Participant has a known allergy or severe reaction to any contrast agent typically used in MRI procedures
  • Participants receiving Gadovist® only - Participant has known renal or hepatic impairment of any intensity or any other kidney/liver disease or has recently undergone kidney/liver transplant
  • Participants receiving Gadovist® only - Participant has a known glomerular filtration rate (eGFR or GFR) of 30 mL/min or less
  • Participants receiving Gadovist® only - Participant has taken part in a clinical research study or clinical study within 30 days prior to enrollment in this study, and/or received contrast agent within 72 hours prior to the study MRI
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02220582
Other Study ID Numbers CAHHM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Montreal Heart Institute
Study Sponsor Montreal Heart Institute
Collaborators Not Provided
Investigators
Principal Investigator: Matthias Friedrich, MD Montreal Heart Institute
Principal Investigator: Sonia Anand, PhD McMaster University
Principal Investigator: Jack Tu, MD Institute for Clinical Evaluative Sciences
PRS Account Montreal Heart Institute
Verification Date February 2020