Cardiovascular DiseasesCVD-10y-postopNCT05732714
Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac Surgery
An observational study of Cardiovascular Diseases and Risk Reduction Behavior, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Risk Reduction Behavior
- What is being tested?
- Healthy lifestyle behaviors around the time of surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-cardiac surgery patients
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Marc Sicova contact
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Wilton vanKlei, MD, 416-340-5164, Wilton.VanKlei@uhn.ca
About this study
Official title: Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Risk Reduction Behavior
- Being tested
- Healthy lifestyle behaviors around the time of surgery
- Keywords
- Intermediate to high risk non-cardiac surgery
- Medical subject headings
- Cardiovascular Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle behaviors around the time of surgeryBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline assessment for calculating the pre-operative 10-year CVD event risk
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.
Measured: 1 month before surgery
Follow-up assessment for calculating the post-operative 10-year CVD event risk
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.
Measured: 3 months after surgery
Secondary outcomes (1)
Occurrence of Cardiovascular or Non-Cardiovascular event
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).
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study startAug 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilton van Klei, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732714
- Sponsor's protocol ID
- 22-5869
- Acronym
- CVD-10y-postop
- Status last verified
- Aug 2024
- First submitted
- 8 Feb 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Cardiovascular Disease Event Risk for Patients Undergoing Major Non-Cardiac
- ClinicalTrials.gov ID
- NCT05732714
- Acronym / sponsor ID
- CVD-10y-postop / 22-5869
- Conditions
- Cardiovascular Diseases, Risk Reduction Behavior
- Keywords
- Intermediate to high risk non-cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-cardiac surgery patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy lifestyle behaviors around the time of surgeryHealthy 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. | Behavioural | – |
Primary outcome
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.
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.
1 secondary outcome
Occurrence of Cardiovascular or Non-Cardiovascular event
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Sicova contact
Wilton van Klei, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Risk Reduction Behavior, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilton van Klei, MD (416-340-5164, Wilton.VanKlei@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline assessment for calculating the pre-operative 10-year CVD event risk (time frame: 1 month before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.