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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05732714
Collaborator
(none)
50
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

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

  1. Occurrence of Cardiovascular or Non-Cardiovascular event [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT05732714
Other Study ID Numbers:
  • 22-5869
First Posted:
Feb 17, 2023
Last Update Posted:
Feb 17, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2023