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Cardiovascular Disease Population Risk Tool (CVDPoRT)

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ClinicalTrials.gov Identifier: NCT02267447
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences
Statistics Canada
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The purpose of this study is to develop, evaluate, and apply a predictive algorithm for assessing CVD risk in the community setting: the Cardiovascular Disease Population Risk Tool (CVDPoRT).

Condition or disease
Cardiovascular Diseases

Detailed Description:
This observational study will use the Ontario sample of the Canadian Community Health Survey (2001, 2003, 2005; 77,251 respondents) to assess risk factors - focusing on health behaviours (physical activity, diet, smoking, and alcohol use). Incident CVD outcomes will be assessed through linkage to administrative healthcare databases (619,886 person-years of follow-up until 31 December 2011). Socio-demographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. Risk prediction models will be developed using competing risks survival analysis. The analysis plan adheres to published recommendations for the development of valid risk prediction models to limit the risk of over-fitting and improve the quality of predictions. Key considerations are fully pre-specifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures that increase the risk of type I error. The 2007 and 2009 surveys (approximately 50,000 respondents) will be used for validation. Calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.

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Study Type : Observational
Actual Enrollment : 104219 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of Cardiovascular Disease in Canada and Burden of Health Behaviours: Development of Population-based Risk Algorithms
Study Start Date : September 2000
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2016

Group/Cohort
Derivation cohort
Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
Validation cohort
Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys.



Primary Outcome Measures :
  1. Major Cardiovascular Disease Event [ Time Frame: up to 12 years ]
    The primary outcome of interest was a major CVD event resulting in hospitalization or sudden death from CVD. Respondents were followed from the survey administration date until the earliest of: incident event, death due to causes other than CVD (defined as a competing risk), loss to follow-up (defined as loss of health care eligibility), or end of study (31 December 2012).


Other Outcome Measures:
  1. Death Due to Causes Other Than CVD [ Time Frame: up to 12 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The derivation cohort will be eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada. The validation cohort will consist of respondents to the 2007 and 2009 surveys.
Criteria

Inclusion Criteria:

  • Respondents to the Canadian Community Health Surveys

Exclusion Criteria:

  • Not eligible for Ontario's universal health insurance program
  • Pregnant
  • Prior history of heart disease or stroke
  • Younger than age 20
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02267447    
Other Study ID Numbers: CIHR FRN - 133550
First Posted: October 17, 2014    Key Record Dates
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final model parameters will be provided in Predictive Modelling Markup Language (PMML) and Lime questionnaire files; as well, we will provide a mock dataset. These files can be used to generate risk estimates in computer applications.
Keywords provided by Ottawa Hospital Research Institute:
Cardiovascular diseases
Clinical prediction rule
Population projection
Risk stratification
Health behavior
Additional relevant MeSH terms:
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Cardiovascular Diseases