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

NCT05732714 | Recruiting

• 1 other identifier: 22-5869
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Risk Reduction Behavior

Keywords

Intermediate to high risk non-cardiac surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Occurrence of Cardiovascular or Non-Cardiovascular event

  30 days after surgery

Interventions

Healthy lifestyle behaviors around the time of surgery BEHAVIORAL

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.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-cardiac surgery patients

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Wilton van Klei, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilton van Klei, MD

CONTACT

416-340-5164; Wilton.VanKlei@uhn.ca

Marc Sicova

CONTACT

marc.sicova@mail.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: August 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CA (1)