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

Cardiovascular Diseases Clinical Trial

— CVD-10y-postop  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05732714
• Other study ID #: 22-5869
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: Wilton van Klei, MD
• Phone: 416-340-5164
• Email: Wilton.VanKlei[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Risk Reduction Behavior

Intervention

Behavioral:
• Healthy 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline assessment for calculating the pre-operative 10-year CVD event risk	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.	1 month before surgery
Primary	Follow-up assessment for calculating the post-operative 10-year CVD event risk	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.	3 months after surgery
Secondary	Occurrence of Cardiovascular or Non-Cardiovascular event	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).	30 days after surgery