Canadian Alliance for Healthy Hearts and Minds

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Intervention Details:

• Other: MRI
  Magnetic Resonance Imaging

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Luu JM, Gebhard C, Ramasundarahettige C, Desai D, Schulze K, Marcotte F, Awadalla P, Broet P, Dummer T, Hicks J, Larose E, Moody A, Smith EE, Tardif JC, Teixeira T, Teo KK, Vena J, Lee DS, Anand SS, Friedrich MG; CAHHM Study Investigators. Normal sex and age-specific parameters in a multi-ethnic population: a cardiovascular magnetic resonance study of the Canadian Alliance for Healthy Hearts and Minds cohort. J Cardiovasc Magn Reson. 2022 Jan 3;24(1):2. doi: 10.1186/s12968-021-00819-z.

Luu JM, Sergeant AK, Anand SS, Desai D, Schulze K, Knoppers BM, Zawati MH, Smith EE, Moody AR, Black SE, Larose E, Marcotte F, Kleiderman E, Tardif JC, Lee DS, Friedrich MG; CAHHM Study Investigators. The impact of reporting magnetic resonance imaging incidental findings in the Canadian alliance for healthy hearts and minds cohort. BMC Med Ethics. 2021 Oct 28;22(1):145. doi: 10.1186/s12910-021-00706-3.

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. doi: 10.1186/s12968-016-0286-6.

• Responsible Party: Montreal Heart Institute
• ClinicalTrials.gov Identifier: NCT02220582
• Other Study ID Numbers: CAHHM
• First Posted: August 20, 2014
• 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:

Cardiovascular Diseases