Clinical trial NCT05732714: Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac Surgery
Official title: Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Risk Reduction Behavior
Keywords: Intermediate to high risk non-cardiac surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-cardiac surgery patients

Brief summary: The goal of this observational study is to learn whether the healthy lifestyle choices made around surgery can influence an individual's long term risk of developing cardiovascular disease. Patients will be observed 1-month prior to and 3-months following surgery to assess their risk of developing cardiovascular disease.

Detailed description: Patients who experience a medical event are often motivated to improve their health by engaging in healthy lifestyle behaviors, such as improving their diet and beginning to exercise. For example, patients who are considered smokers prior to surgery may sometimes stop smoking following surgery. However, we are unsure of other changes following surgery. For example, we are unsure if surgery can initiate any changes in exercise and diet, and we are unsure if these changes can influence the risk of developing cardiovascular disease. Consistent and positive lifestyle changes will likely reduce an individual's risk of developing cardiovascular disease in the long term.

Eligibility criteria: Inclusion Criteria:

* Age 45 - 75 years
* Scheduled for intermediate- to high risk non-cardiac surgery (intra-thoracic or intra-abdominal surgery, all vascular surgery, intra-cranial neurosurgery, spine surgery)
* Expected post-operative length of stay of at least two days, according to the surgeon's expectation
* At least two of the following CVD risk factors:

History of: Hypertension, Diabetes, Coronary artery disease, Chronic heart failure, Chronic kidney disease, Cerebrovascular disease, Peripheral vascular disease.

Obesity (BMI \>25 kg/m2), Current smoking, Poor exercise capacity (\<4 METS)

Exclusion Criteria:

* Currently participating in a CVD risk reduction program
* Patient is scheduled to undergo transplant or has undergone emergency surgery
* Life expectancy \<1 year (palliative surgery)
* Recent (\<6 months) myocardial infarction or stroke
* Surgery scheduled \<1 month
* Inability to effectively communicate

Primary outcomes:
measure: Baseline assessment for calculating the pre-operative 10-year CVD event risk
timeFrame: 1 month before surgery
measure: Follow-up assessment for calculating the post-operative 10-year CVD event risk
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Occurrence of Cardiovascular or Non-Cardiovascular event
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Wilton van Klei, MD
role: PRINCIPAL_INVESTIGATOR
References: