To determine changes (i.e. pre- vs. postoperative) in 10-year cardiovascular disease (CVD) event risk according to contemporary widely applicable risk models in patients with CVD risk factors who have undergone intermediate-to-high-risk non-cardiac…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is (change in) estimated 10 year CVD event risk.
Secondary outcome
A secondary outcome is number of patients that complete the study.
Background summary
Rationale: Current estimates suggest that 5% of patients who undergo
intermediate-to-high-risk non-cardiac surgery experience an adverse cardiac
event (e.g. mortality, myocardial infarction) within 30-days of surgery (i.e.
perioperative period). Experiencing an adverse event, such as a stroke or
myocardial infraction, can be considered a teachable moment for the patient,
which may initiate spontaneous lifestyle modifications.
Study objective
To determine changes (i.e. pre- vs. postoperative) in 10-year cardiovascular
disease (CVD) event risk according to contemporary widely applicable risk
models in patients with CVD risk factors who have undergone
intermediate-to-high-risk non-cardiac surgery. Also, willingness of patients to
complete the study will be inventoried
Study design
This is a prospective observational pilot study among non-cardiac surgery
patients, with an aim to include 50 participants. Baseline assessments will
occur prior to the patients scheduled surgery. Follow up assessments will
occur 3 months after surgery.
Study burden and risks
Participants will complete 2 site visits, with each consisting of a blood test,
electrocardiogram, urine sampling and questionnaires that will be used to
subjectively assess their physical fitness. Participating in this study does
not carry an additional risk as compared to standard clinical care.
Elisabeth street 200
Toronto, ON M5G 2C4
CA
Elisabeth street 200
Toronto, ON M5G 2C4
CA
Listed location countries
Age
Inclusion criteria
1. Age 45 - 75 years
2. Scheduled for intermediate- to high risk non-cardiac surgery (intra-thoracic
or intra-abdominal surgery, all vascular surgery, intra-cranial neurosurgery,
spine surgery)
3. Expected postoperative length of stay of at least two days, according to the
surgeon*s expectation
4. At least two of the following CVD risk factors:
o History of: Hypertension, Diabetes, Coronary artery disease, Chronic heart
failure, Chronic kidney disease, Cerebrovascular disease, Peripheral vascular
disease
o Obesity (BMI >25 kg/m2), Current smoking, Poor exercise capacity (<4 METS)
Exclusion criteria
1. Currently participating in a CVD risk reduction program
2. Patient is scheduled to undergo transplant or has undergone emergency
surgery
3. Life expectancy <1 year (palliative surgery)
4. Recent (<6 months) myocardial infarction or stroke
5. Inability to effectively communicate
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84271.041.23 |