Canadian Alliance for Healthy Hearts and Minds

NCT02220582 | Completed

• 1 other identifier: CAHHM
• Study Type: observational
• Target: 7,900
• Locations: 1 country
• Sites: 12

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

Conditions

Cardiovascular Diseases

Keywords

Cardiac Magnetic Resonance (CMR); Cardiovascular Diseases; socio-environmental factors; Contextual factors

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Congestive Heart Failure

  After completion of MRI and during follow-up period (2 to 3 years)

• New onset established risk factors

  After completion of MRI and during follow-up period (2 to 3 years)

• Risk markers acquired through imaging and blood samples

  After completion of MRI and during follow-up period (2 to 3 years)

Interventions

MRI OTHER

Magnetic Resonance Imaging

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (12)

Seaman Family MR Research Center

Calgary, Alberta, T2N2T9, Canada

Location

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H3A7, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Robarts Research Institute

London, Ontario, N6A1G9, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Montreal Heart Insitute

Montreal, Quebec, H1T 1C8, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A3J1, Canada

Location

IUCPQ

Ste Foy, Quebec, G1V4G5, Canada

Location

Related Publications (3)

• 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.

  PMID: 34980185 DERIVED

• 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.

  PMID: 34711210 DERIVED

• 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.

  PMID: 27716344 DERIVED

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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Matthias Friedrich, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Sonia Anand, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jack Tu, MD

  Institute for Clinical Evaluative Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: April 1, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CA (12)