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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02220582 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Canadian Alliance for Healthy Hearts and Minds
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Scientific title:
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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 |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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7900 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02220582 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jack Tu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute for Clinical Evaluative Sciences |
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Name:
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Sonia Anand, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Name:
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Matthias Friedrich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montreal Heart Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
35 Years
Age maximum:
69 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Intervention(s)
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Other: MRI
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Primary Outcome(s)
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Stroke
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Coronary Artery Bypass Graft
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Percutaneous Transluminal Coronary Angioplasty
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Myocardial Infarction (MI)
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Percutaneous Coronary Intervention
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Secondary Outcome(s)
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Risk markers acquired through imaging and blood samples
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Congestive Heart Failure
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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New onset established risk factors
[Time Frame: After completion of MRI and during follow-up period (2 to 3 years)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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