An observational study in Cardiovascular Diseases, sponsored by Ottawa Hospital Research Institute. Completed. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-07.
Sponsored by Ottawa Hospital Research Institute · Observational
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).
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 104,219 is above the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Ottawa Hospital Research Institute is the lead sponsor of 544 studies on the registry; 97 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.
Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys.
Major Cardiovascular Disease Event
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).
Time frame: up to 12 years
Death Due to Causes Other Than CVD
Time frame: up to 12 years
| Milestone | Derivation Cohort | Validation Cohort |
|---|---|---|
| Started | 77251 | 26968 |
| Completed | 77251 | 26968 |
| Not completed | 0 | 0 |
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).
| Cardiovascular disease event | Derivation Cohort | Validation Cohort |
|---|---|---|
| Major Cardiovascular Disease Event | 3182 | 527 |
| deaths | Derivation Cohort | Validation Cohort |
|---|---|---|
| Death Due to Causes Other Than CVD | 3538 | 979 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Derivation Cohort | — | — | — |
| Validation Cohort | — | — | — |
Ontario respondents of CCHS survey cycles 1.1, 2.1, 3.1 and 4.1 (conducted in 2001, 2003, 2005 and 2007, respectively). Respondents were excluded if they were not eligible for Ontario's universal health insurance program, were pregnant, self-reported a prior history of heart disease or stroke, or were age \<20 at the time of survey administration.
| Age, Continuous(years) | Derivation Cohort | Validation Cohort | Total |
|---|---|---|---|
| Female | 48.0 (35.0 to 63.0) | 51.0 (37.0 to 64.0) | 49.5 (36.0 to 63.5) |
| Male | 46.0 (35.0 to 59.0) | 48.0 (35.0 to 63.0) | 47.0 (35.0 to 61.0) |
| Sex: Female, Male(Participants) | Derivation Cohort | Validation Cohort | Total |
|---|---|---|---|
| Female | 42185 | 14801 | 56986 |
| Male | 35066 | 12167 | 47233 |
No study locations are listed for this record.
Plan to share: Yes — 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.
The record gives a start of Sep 2000, a primary completion of Dec 2014 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2017, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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