Cardiovascular Disease Population Risk Tool

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT02267447
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2014-12
• Study Completion: 2016-04
• Results First Submitted: 2016-09-27
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Results First Posted: 2017-08-07
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104219

Inclusion Criteria

• Respondents to the Canadian Community Health Surveys

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Exclusion Criteria

• Not eligible for Ontario's universal health insurance program
• Pregnant
• Prior history of heart disease or stroke
• Younger than age 20

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Cardiovascular Disease Event	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).