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Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac Surgery

Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05732714
Acronym
CVD-10y-postop
Enrollment
50
Registered
2023-02-17
Start date
2024-08-31
Completion date
2025-10-31
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Risk Reduction Behavior

Keywords

Intermediate to high risk non-cardiac surgery

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.

Interventions

BEHAVIORALHealthy lifestyle behaviors around the time of surgery

Healthy lifestyle choices, such as improving diet and beginning to exercise around the time of surgery and it's influence on an individual's long term risk of developing cardiovascular disease.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline assessment for calculating the pre-operative 10-year CVD event risk1 month before surgeryFor the baseline assessment, the expected 10-year CVD event risk of each participant will be calculated according to the appropriate CVD event risk prediction score using blood tests, questionnaire to estimate an individual's functional capacity, blood pressure, heart rate and ECG.
Follow-up assessment for calculating the post-operative 10-year CVD event risk3 months after surgeryFor the follow-up assessment, the expected 10-year CVD event risk of each participant will be calculated according to the appropriate CVD event risk prediction score using blood tests, questionnaire to estimate an individual's functional capacity, blood pressure, heart rate and ECG.

Secondary

MeasureTime frameDescription
Occurrence of Cardiovascular or Non-Cardiovascular event30 days after surgeryCardiovascular related (e.g. Myocardial infarction/injury, mortality, heart failure) or non-cardiovascular related (e.g. surgical site infections, unexpected critical care unit admissions, re-operations).

Countries

Canada

Contacts

Primary ContactWilton van Klei, MD
Wilton.VanKlei@uhn.ca416-340-5164
Backup ContactMarc Sicova
marc.sicova@mail.utoronto.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026