Canadian Alliance for Healthy Hearts and Minds

Sponsor

Montreal Heart Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02220582

Collaborator

(none)

7,900

Enrollment

Locations

Actual Duration (Months)

658.3

Patients Per Site

10.1

Patients Per Site Per Month

Study Details

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	Phase
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 :

Nov 1, 2013

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Apr 1, 2019

Outcome Measures

Primary Outcome Measures

Myocardial Infarction (MI) [After completion of MRI and during follow-up period (2 to 3 years)]
Stroke [After completion of MRI and during follow-up period (2 to 3 years)]
Percutaneous Transluminal Coronary Angioplasty [After completion of MRI and during follow-up period (2 to 3 years)]
Percutaneous Coronary Intervention [After completion of MRI and during follow-up period (2 to 3 years)]
Coronary Artery Bypass Graft [After completion of MRI and during follow-up period (2 to 3 years)]

Secondary Outcome Measures

Congestive Heart Failure [After completion of MRI and during follow-up period (2 to 3 years)]
Congestive Heart Failure requiring hospitalization
New onset established risk factors [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Seaman Family MR Research Center	Calgary	Alberta	Canada	T2N2T9
2	University of Calgary	Calgary	Alberta	Canada	T2N4N1
3	St Paul's Hospital	Vancouver	British Columbia	Canada	V6Z1Y6
4	QEII Health Sciences Center	Halifax	Nova Scotia	Canada	B3H3A7
5	St. Joseph's Healthcare	Hamilton	Ontario	Canada	L8N 4A6
6	Robarts Research Institute	London	Ontario	Canada	N6A1G9
7	Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y4W7
8	Sunnybrook Health Sciences Center	Toronto	Ontario	Canada	M4N3M5
9	St Michael's Hospital	Toronto	Ontario	Canada	M5B1W8
10	Montreal Heart Insitute	Montreal	Quebec	Canada	H1T 1C8
11	McGill University Health Center	Montreal	Quebec	Canada	H4A3J1
12	IUCPQ	Ste Foy	Quebec	Canada	G1V4G5