Clinical trial NCT02267447: Cardiovascular Disease Population Risk Tool
Official title: Risk of Cardiovascular Disease in Canada and Burden of Health Behaviours: Development of Population-based Risk Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular diseases
Clinical prediction rule
Population projection
Risk stratification
Health behavior
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Institute for Clinical Evaluative Sciences
name: Statistics Canada
First posted: 2014-10-17
Enrollment: 104219
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Major Cardiovascular Disease Event
timeFrame: up to 12 years
Secondary outcomes:
Other outcomes:
measure: Death Due to Causes Other Than CVD
timeFrame: up to 12 years
Locations:
Study officials:
References:
citation: Manuel DG, Tuna M, Bennett C, Hennessy D, Rosella L, Sanmartin C, Tu JV, Perez R, Fisher S, Taljaard M. Development and validation of a cardiovascular disease risk-prediction model using population health surveys: the Cardiovascular Disease Population Risk Tool (CVDPoRT). CMAJ. 2018 Jul 23;190(29):E871-E882. doi: 10.1503/cmaj.170914.
citation: Taljaard M, Tuna M, Bennett C, Perez R, Rosella L, Tu JV, Sanmartin C, Hennessy D, Tanuseputro P, Lebenbaum M, Manuel DG. Cardiovascular Disease Population Risk Tool (CVDPoRT): predictive algorithm for assessing CVD risk in the community setting. A study protocol. BMJ Open. 2014 Oct 23;4(10):e006701. doi: 10.1136/bmjopen-2014-006701.