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

NCT ID: NCT05732714

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Risk Reduction Behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilton van Klei, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Wilton van Klei, MD

Role: CONTACT

416-340-5164

Marc Sicova

Role: CONTACT

Facility Contacts

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Wilton vanKlei, MD

Role: primary

416-340-5164

Other Identifiers

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22-5869

Identifier Type: -

Identifier Source: org_study_id

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