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

Recruiting

• Conditions: Cardiovascular Diseases; Risk Reduction Behavior

• Registration Number: NCT05732714
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-04
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline assessment for calculating the pre-operative 10-year CVD event risk	1 month before surgery	For 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 risk	3 months after surgery	For 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 Outcome Measures

Name	Time	Method
Occurrence of Cardiovascular or Non-Cardiovascular event	30 days after surgery	Cardiovascular 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).

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada