Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac Surgery (CVD-10y-postop)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Risk Reduction Behavior
• Intervention / Treatment: Behavioral: Healthy lifestyle behaviors around the time of surgery

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Wilton van Klei, MD; Phone Number: 416-340-5164; Email: Wilton.VanKlei@uhn.ca
• Study Contact Backup: Name: Marc Sicova; Email: marc.sicova@mail.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital
      • Contact: Wilton vanKlei, MD; Phone Number: 416-340-5164; Email: Wilton.VanKlei@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Non-cardiac surgery patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Wilton van Klei, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Intermediate to high risk non-cardiac surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 22-5869

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No