NCT02267447

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104,219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

April 1, 2017

Enrollment Period

14.3 years

First QC Date

October 6, 2014

Results QC Date

September 27, 2016

Last Update Submit

April 26, 2017

Conditions

Keywords

Cardiovascular diseasesClinical prediction rulePopulation projectionRisk stratificationHealth behavior

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to 12 years

Other Outcomes (1)

  • Death Due to Causes Other Than CVD

    up to 12 years

Study Arms (2)

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Respondents to the Canadian Community Health Surveys

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Doug Manuel
Organization
Ottawa Hospital Research Institute

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 17, 2014

Study Start

September 1, 2000

Primary Completion

December 1, 2014

Study Completion

April 1, 2016

Last Updated

August 7, 2017

Results First Posted

August 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

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.