Cardiovascular Disease Population Risk Tool

NCT ID: NCT02267447

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104219 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Derivation cohort

Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.

No interventions assigned to this group

Validation cohort

Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys.

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role: collaborator

Statistics Canada

UNKNOWN

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 30037888 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25341454 (View on PubMed)

Other Identifiers

CIHR FRN - 133550

Identifier Type: -

Identifier Source: org_study_id