Canadian Alliance for Healthy Hearts and Minds

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220582
• Other study ID #: CAHHM
• Status: Completed
• Start date: November 2013
• Est. completion date: April 2019

Study information

• Verified date: February 2020
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7900
• Est. completion date: April 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• MRI
Magnetic Resonance Imaging

Locations

Country	Name	City	State
Canada	Seaman Family MR Research Center	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
Canada	QEII Health Sciences Center	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Robarts Research Institute	London	Ontario
Canada	McGill University Health Center	Montreal	Quebec
Canada	Montreal Heart Insitute	Montreal	Quebec
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	IUCPQ	Ste Foy	Quebec
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Infarction (MI)		After completion of MRI and during follow-up period (2 to 3 years)
Primary	Stroke		After completion of MRI and during follow-up period (2 to 3 years)
Primary	Percutaneous Transluminal Coronary Angioplasty		After completion of MRI and during follow-up period (2 to 3 years)
Primary	Percutaneous Coronary Intervention		After completion of MRI and during follow-up period (2 to 3 years)
Primary	Coronary Artery Bypass Graft		After completion of MRI and during follow-up period (2 to 3 years)
Secondary	Congestive Heart Failure	Congestive Heart Failure requiring hospitalization	After completion of MRI and during follow-up period (2 to 3 years)
Secondary	New onset established risk factors	Incident diagnosis of diabetes by physician; Incident diagnosis of arterial hypertension by physician; Incident diagnosis of significant cognitive dysfunction (i.e. dementia) by physician.	After completion of MRI and during follow-up period (2 to 3 years)
Secondary	Risk markers acquired through imaging and blood samples	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	After completion of MRI and during follow-up period (2 to 3 years)