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Canadian Alliance for Healthy Hearts and Minds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
Cardiovascular Diseases Other: MRI

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.

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Study Type : Observational
Actual Enrollment : 7900 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : April 2019

Intervention Details:
  • Other: MRI
    Magnetic Resonance Imaging


Primary Outcome Measures :
  1. Myocardial Infarction (MI) [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  2. Stroke [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  3. Percutaneous Transluminal Coronary Angioplasty [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  4. Percutaneous Coronary Intervention [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
  5. Coronary Artery Bypass Graft [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]

Secondary Outcome Measures :
  1. Congestive Heart Failure [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ]
    Congestive Heart Failure requiring hospitalization

  2. 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.

  3. 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


Biospecimen Retention:   Samples With DNA
The study will precisely phenotype individuals with respect to cardiac, vascular and cognitive dysfunction and to identify novel targets for indicators of early disease.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220582


Locations
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Canada, Alberta
Seaman Family MR Research Center
Calgary, Alberta, Canada, T2N2T9
University of Calgary
Calgary, Alberta, Canada, T2N4N1
Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H3A7
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Robarts Research Institute
London, Ontario, Canada, N6A1G9
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N3M5
St Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
Montreal Heart Insitute
Montreal, Quebec, Canada, H1T 1C8
McGill University Health Center
Montreal, Quebec, Canada, H4A3J1
IUCPQ
Ste Foy, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Montreal Heart Institute
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02220582    
Other Study ID Numbers: CAHHM
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Keywords provided by Montreal Heart Institute:
Cardiac Magnetic Resonance (CMR)
Cardiovascular Diseases
socio-environmental factors
Contextual factors
Additional relevant MeSH terms:
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Cardiovascular Diseases