Status:

COMPLETED

Canadian Alliance for Healthy Hearts and Minds

Lead Sponsor:

Montreal Heart Institute

Conditions:

Cardiovascular Diseases

Eligibility:

All Genders

35-69 years

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 a...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2019

Estimated Enrollment :

7900 Patients enrolled

Trial Details

Trial ID

NCT02220582

Start Date

November 1 2013

End Date

April 1 2019

Last Update

February 21 2020

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

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

Canadian Alliance for Healthy Hearts and Minds | DecenTrialz