Trial Outcomes & Findings for Cardiovascular Disease Population Risk Tool (NCT NCT02267447)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

104219 participants

Primary outcome timeframe

up to 12 years

Results posted on

2017-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	77251	26968
Overall Study COMPLETED	77251	26968
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardiovascular Disease Population Risk Tool

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Derivation Cohort n=77 Participants Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.	Validation Cohort n=26 Participants Eligible respondents to the 2007/2008 Canadian Community Health Survey.	Total n=104219 Participants Total of all reporting groups
Age, Continuous Female	48.0 years n=5 Participants	51.0 years n=7 Participants	49.5 years n=5 Participants
Age, Continuous Male	46.0 years n=5 Participants	48.0 years n=7 Participants	47.0 years n=5 Participants
Sex: Female, Male Female	42185 Participants n=5 Participants	14801 Participants n=7 Participants	56986 Participants n=5 Participants
Sex: Female, Male Male	35066 Participants n=5 Participants	12167 Participants n=7 Participants	47233 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Derivation Cohort n=687135 person-years Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.	Validation Cohort n=131343 person-years Eligible respondents to the 2007 /2008 Canadian Community Health Surveys.
Major Cardiovascular Disease Event	3182 Cardiovascular disease event	527 Cardiovascular disease event

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 12 years

Outcome measures

Outcome measures
Measure	Derivation Cohort n=77251 Participants Eligible respondents to the combined 2001, 2003 and 2005 Canadian Community Health Surveys, conducted by Statistics Canada.	Validation Cohort n=26968 Participants Eligible respondents to the 2007 /2008 Canadian Community Health Surveys.
Death Due to Causes Other Than CVD	3538 deaths	979 deaths

Adverse Events

Derivation Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Validation Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Doug Manuel

Ottawa Hospital Research Institute

Phone: 613-798-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place