Canadian Alliance for Healthy Hearts and Minds
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02220582 |
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Recruitment Status :
Completed
First Posted : August 20, 2014
Last Update Posted : February 21, 2020
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Sponsor:
Montreal Heart Institute
Information provided by (Responsible Party):
Montreal Heart Institute
| Tracking Information | ||||||||||
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| First Submitted Date | August 18, 2014 | |||||||||
| First Posted Date | August 20, 2014 | |||||||||
| Last Update Posted Date | February 21, 2020 | |||||||||
| Actual Study Start Date | November 2013 | |||||||||
| Actual Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
Miocardial Infarction (MI), Stroke, Percutaneous Transluminal Coronary Angioplasty(PTCA) or Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG), new diagnosis of cancer, Death [ Time Frame: After completion of MRI and during follow-up period (2 to 3 years) ] The primary outcomes include MI, Stroke, PTCA/PCI, CABG, new diagnosis of cancer, and Death.
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Canadian Alliance for Healthy Hearts and Minds | |||||||||
| 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 | |||||||||
| 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:
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| 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 Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: The study will precisely phenotype individuals with respect to cardiac, vascular and cognitive dysfunction and to identify novel targets for indicators of early disease.
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| 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. |
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| Condition | Cardiovascular Diseases | |||||||||
| Intervention | Other: MRI
Magnetic Resonance Imaging
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| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | 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. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
7900 | |||||||||
| Original Estimated Enrollment |
9700 | |||||||||
| Actual Study Completion Date | April 2019 | |||||||||
| Actual Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 35 Years to 69 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Canada | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT02220582 | |||||||||
| Other Study ID Numbers | CAHHM | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Montreal Heart Institute | |||||||||
| Study Sponsor | Montreal Heart Institute | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Montreal Heart Institute | |||||||||
| Verification Date | February 2020 | |||||||||