Clinical trial NCT02220582: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Cardiac Magnetic Resonance (CMR)
Cardiovascular Diseases
socio-environmental factors
Contextual factors
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 7900
Sex: ALL
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Myocardial Infarction (MI)
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Stroke
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Percutaneous Transluminal Coronary Angioplasty
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Percutaneous Coronary Intervention
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Coronary Artery Bypass Graft
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
Secondary outcomes:
measure: Congestive Heart Failure
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
measure: New onset established risk factors
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
measure: Risk markers acquired through imaging and blood samples
timeFrame: After completion of MRI and during follow-up period (2 to 3 years)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Seaman Family MR Research Center
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
facility: Robarts Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Insitute
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Ste Foy
country: Canada
facility: IUCPQ
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Matthias Friedrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Sonia Anand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical Evaluative Sciences
name: Jack Tu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.