Cardiovascular DiseasesCVDPoRTNCT02267447
Cardiovascular Disease Population Risk Tool
An observational study of Cardiovascular Diseases, run by Ottawa Hospital Research Institute.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 104,219 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Apr 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Respondents to the Canadian Community Health Surveys
Who cannot join
- Not eligible for Ontario's universal health insurance program
- Pregnant
- Prior history of heart disease or stroke
- Younger than age 20
About this study
Official title: Risk of Cardiovascular Disease in Canada and Burden of Health Behaviours: Development of Population-based Risk Algorithms
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).
Read the 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
- Keywords
- Cardiovascular diseases, Clinical prediction rule, Population projection, Risk stratification, Health behavior
- Medical subject headings
- Cardiovascular Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Derivation cohort | Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada. | |
| Validation cohort | Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startSep 2000
- Primary completionDec 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Statistics Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267447
- Sponsor's protocol ID
- CIHR FRN - 133550
- Acronym
- CVDPoRT
- Status last verified
- Apr 2017
- First submitted
- 6 Oct 2014
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30037888Taljaard 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.
PubMed 25341454
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Cardiovascular Disease in Canada and Burden of Health Behaviours: Development of Population-based Risk Algorithms
- ClinicalTrials.gov ID
- NCT02267447
- Acronym / sponsor ID
- CVDPoRT / CIHR FRN - 133550
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular diseases, Clinical prediction rule, Population projection, Risk stratification, Health behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104,219 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Statistics Canada
- Study start
- Sep 2000
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation cohort | – | –Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada. |
| Validation cohort | – | –Eligible respondents to the 2007 and 2009 Canadian Community Health Surveys. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Respondents to the Canadian Community Health Surveys
Key exclusion criteria (4 listed)
- Not eligible for Ontario's universal health insurance program
- Pregnant
- Prior history of heart disease or stroke
- Younger than age 20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Cardiovascular Disease Event
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30037888Manuel 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.
- Derived from this study: PubMed 25341454Taljaard 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cardiovascular Disease Event (time frame: up to 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267447, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.