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临床试验/NCT02267447
NCT02267447已完成不适用

Risk of Cardiovascular Disease in Canada and Burden of Health Behaviours: Development of Population-based Risk Algorithms

Ottawa Hospital Research Institute0 个研究点目标入组 104,219 人开始时间: 2000年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104,219
主要终点
Major Cardiovascular Disease Event

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Respondents to the Canadian Community Health Surveys

排除标准

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

结局指标

主要结局

Major Cardiovascular Disease Event

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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