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Recruiting NCT05732714

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

Observational Cardiovascular Diseases Risk Reduction Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy lifestyle behaviors around the time of surgery.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, Risk Reduction Behavior. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Occurrence of Cardiovascular or Non-Cardiovascular event [Time frame: 30 days after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Toronto General Hospital — Toronto

Identifiers

NCT: NCT05732714 · 22-5869

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗