Recruiting

Cardiovascular Risk

Sponsor:

University Health Network, Toronto

Code:

NCT05732714

Conditions

Cardiovascular Diseases

Risk Reduction Behavior

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Healthy lifestyle behaviors around the time of surgery

Study Details

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

Study ID

NCT05732714

Start date

Aug, 2024

Status verified date

Aug, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Baseline assessment for calculating the pre-operative 10-year CVD event risk [ Time Frame: 1 month before surgery ]
  • Follow-up assessment for calculating the post-operative 10-year CVD event risk [ Time Frame: 3 months after surgery ]

Central Contacts and Locations

Central contacts

Wilton van Klei, MD

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

Marc Sicova

marc.sicova@mail.utoronto.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Wilton vanKlei, MD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 13, 2024

Last verified

Aug, 2024

Keywords

  • Intermediate to high risk non-cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-08-13.