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NCT Number: NCT05732714

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

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.

Recruiting

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

Location contact

Wilton vanKlei, MD

CONTACT

[email protected]

416-340-5164

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Baseline assessment for calculating the pre-operative 10-year CVD event risk

    Time frame: 1 month before surgery

    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.

  2. Follow-up assessment for calculating the post-operative 10-year CVD event risk

    Time frame: 3 months after surgery

    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.

Secondary outcomes

  1. Occurrence of Cardiovascular or Non-Cardiovascular event

    Time frame: 30 days after surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Sicova

CONTACT

[email protected]

Wilton van Klei, MD

CONTACT

[email protected]

416-340-5164

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: CVD-10y-postop

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2023
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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