Perioperative ComplicationNCT05333146
Outcomes After Perioperative Stroke Following Cardiac Surgery
An observational study of Perioperative Complication and Stroke, Acute, run by University of British Columbia at 1 site in Canada.
Trial summary
Perioperative stroke is a devastating complication of cardiac surgery that is currently poorly characterized but occurs in 1-5% of patients and is associated with poor outcomes including increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication, Stroke, Acute, Stroke, Complication
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 906 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2022to 1 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who received a diagnosis of stroke in the NSQIP database after a cardiac surgical procedure between 2005 and 2020.
Who may be able to join
- Experienced a perioperative stroke
- Underwent cardiac surgery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia
Alana Flexman, MD
About this study
Perioperative stroke is a devastating complication of cardiac surgery that is currently poorly characterized but occurs in 1-5% of patients and is associated with poor outcomes including increased mortality. Given the uncommon nature of this complication, relatively little is known about which factors predict these outcomes among those who experience a perioperative stroke. The study objectives are to identify predictors of mortality, length of stay and discharge disposition after perioperative stroke in cardiac surgery using the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program database between 2005 and 2020.
Read the detailed description
BACKGROUND Perioperative stroke is a devastating complication of cardiac surgery that is currently poorly characterized. Perioperative stroke is a cerebrovascular event that occurs after cardiac surgery, and affects between1-5% of patients. The current literature has identified that patients who experience a stroke after surgery have a higher rate of mortality, length of stay and discharge to a facility, but given the rare nature of this complication less is known about which factors predict these outcomes among those who experience a perioperative stroke.
OBJECTIVES
- Derive and externally validate risk prediction models for mortality (primary outcome), adverse discharge, and length of stay after perioperative stroke.
- Describe temporal trends in mortality after perioperative stroke between 2005 and 2020.
METHODS This study is a retrospective analysis of the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program database between 2004 and 2020. The study cohort will be extracted from the NSQIP database and include all patients who experienced a stroke within 30 days of surgery and who underwent a cardiac surgical procedure.
STUDY POPULATION Patients who underwent any cardiac surgical procedure and who experienced a perioperative stroke in the NSQIP database between 2005 and 2020 will be included.
OUTCOMES Primary outcome is 30-day mortality; secondary outcomes are length of hospital stay and adverse discharge (non-home facility or death).
Candidate predictor variables: Outcome after perioperative stroke is potentially related to patient, surgical, and anesthetic factors, as well as characteristics of the stroke. Candidate predictor variables will include patient characteristics (age, sex, comorbidities), surgical characteristics (complexity, type, emergency status, aortic surgery), postoperative complications (cardiac arrest, myocardial ischemia, transfusion) and stroke characteristics (severity as determined by associated tracheostomy or craniectomy), timing relative to operation, readmission for stroke vs inpatient stroke). Continuous variables will be considered for transformation using fractional polynomials to allow a continuous non-linear association.
ANALYSIS Multivariable models to predict 30-day mortality (primary outcome), adverse discharge and length of stay will be created. To avoid over-fitting, we will undertake a data reduction strategy and exclude variables with greater than 10% missing data or less than 20 observations, where >1% but <10% data are missing, we will consider multiple or mean imputation.
Pre-specified predictor variables will be used to construct a logistic regression model using a principle component analysis. We will a priori examine the following interactions: age*gender, surgical complexity (operation time)*age. Given the potential differential mechanisms of early (<48h) and late (>48h and <30 days) perioperative stroke, we will include days from surgery to event as both a continuous and categorical variable.
Model discrimination will be evaluated using the area under the receiver operating characteristic curve (c-statistic). Model calibration will be assessed with a loess smoothed plot of observed vs predicted risks over the risk spectrum. A similar analysis will be used to create a prediction model for length of stay. As death is a competing outcome for discharge disposition, adverse discharge will be modelled as an ordinal outcome (home, non-home discharge, or death). Following derivation, 5,000 bootstrap samples will be used for internal validation.
Temporal trends in mortality will be analyzed first using an exploratory unadjusted ordinary least squares regression model with annual mortality rate after perioperative stroke as the dependent variable and year as the predictor to estimate the yearly change in mortality rate over time. A multivariable linear regression model will be specified, adjusting for important predictors.
- Conditions
- Perioperative Complication, Stroke, Acute, Stroke, Complication, Stroke, Cardiovascular, Cardiovascular Diseases
- Being tested
- Cardiac Surgery
- Medical subject headings
- Stroke, Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Cardiac surgery (e.g. coronary bypass surgery, cardiac valve surgery, ascending aortic surgery)
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death
Measured: Within 30 days of surgery
Secondary outcomes (2)
Adverse discharge
Discharge to a non-home facility or death
Measured: Within 30 days of surgery
Length of stay
Length of hospital stay
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start18 Apr 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Retrospective
- Enrolment
- 906 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana Flexman, University of British Columbia
- Investigators
- Alana Flexman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333146
- Sponsor's protocol ID
- H21-03915
- Status last verified
- Jun 2022
- First submitted
- 11 Apr 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The NSQIP data is available upon request to investigators at participating sites. We will not directly share our dataset as per the NSQIP Participant Data Use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Perioperative Stroke Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05333146
- Acronym / sponsor ID
- H21-03915
- Conditions
- Perioperative Complication, Stroke, Acute, Stroke, Complication, Stroke, Cardiovascular, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 906 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 Apr 2022 (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.
Perioperative stroke is a devastating complication of cardiac surgery that is currently poorly characterized but occurs in 1-5% of patients and is associated with poor outcomes including increased mortality. Given the uncommon nature of this complication, relatively little is known about which factors predict these outcomes among those who experience a perioperative stroke. The study objectives are to identify predictors of mortality, length of stay and discharge disposition after perioperative stroke in cardiac surgery using the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program database between 2005 and 2020.
Detailed description
BACKGROUND Perioperative stroke is a devastating complication of cardiac surgery that is currently poorly characterized. Perioperative stroke is a cerebrovascular event that occurs after cardiac surgery, and affects between1-5% of patients. The current literature has identified that patients who experience a stroke after surgery have a higher rate of mortality, length of stay and discharge to a facility, but given the rare nature of this complication less is known about which factors predict these outcomes among those who experience a perioperative stroke.
OBJECTIVES
- Derive and externally validate risk prediction models for mortality (primary outcome), adverse discharge, and length of stay after perioperative stroke.
- Describe temporal trends in mortality after perioperative stroke between 2005 and 2020.
METHODS This study is a retrospective analysis of the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program database between 2004 and 2020. The study cohort will be extracted from the NSQIP database and include all patients who experienced a stroke within 30 days of surgery and who underwent a cardiac surgical procedure.
STUDY POPULATION Patients who underwent any cardiac surgical procedure and who experienced a perioperative stroke in the NSQIP database between 2005 and 2020 will be included.
OUTCOMES Primary outcome is 30-day mortality; secondary outcomes are length of hospital stay and adverse discharge (non-home facility or death).
Candidate predictor variables: Outcome after perioperative stroke is potentially related to patient, surgical, and anesthetic factors, as well as characteristics of the stroke. Candidate predictor variables will include patient characteristics (age, sex, comorbidities), surgical characteristics (complexity, type, emergency status, aortic surgery), postoperative complications (cardiac arrest, myocardial ischemia, transfusion) and stroke characteristics (severity as determined by associated tracheostomy or craniectomy), timing relative to operation, readmission for stroke vs inpatient stroke). Continuous variables will be considered for transformation using fractional polynomials to allow a continuous non-linear association.
ANALYSIS Multivariable models to predict 30-day mortality (primary outcome), adverse discharge and length of stay will be created. To avoid over-fitting, we will undertake a data reduction strategy and exclude variables with greater than 10% missing data or less than 20 observations, where >1% but <10% data are missing, we will consider multiple or mean imputation.
Pre-specified predictor variables will be used to construct a logistic regression model using a principle component analysis. We will a priori examine the following interactions: age*gender, surgical complexity (operation time)*age. Given the potential differential mechanisms of early (<48h) and late (>48h and <30 days) perioperative stroke, we will include days from surgery to event as both a continuous and categorical variable.
Model discrimination will be evaluated using the area under the receiver operating characteristic curve (c-statistic). Model calibration will be assessed with a loess smoothed plot of observed vs predicted risks over the risk spectrum. A similar analysis will be used to create a prediction model for length of stay. As death is a competing outcome for discharge disposition, adverse discharge will be modelled as an ordinal outcome (home, non-home discharge, or death). Following derivation, 5,000 bootstrap samples will be used for internal validation.
Temporal trends in mortality will be analyzed first using an exploratory unadjusted ordinary least squares regression model with annual mortality rate after perioperative stroke as the dependent variable and year as the predictor to estimate the yearly change in mortality rate over time. A multivariable linear regression model will be specified, adjusting for important predictors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who received a diagnosis of stroke in the NSQIP database after a cardiac surgical procedure between 2005 and 2020.
Key inclusion criteria (2 listed)
- Experienced a perioperative stroke
- Underwent cardiac surgery
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Cardiac SurgeryCardiac surgery (e.g. coronary bypass surgery, cardiac valve surgery, ascending aortic surgery) | Procedure or surgery | – |
Primary outcome
Death
Time frame: Within 30 days of surgery
Death
2 secondary outcomes
Adverse discharge
Time frame: Within 30 days of surgery
Length of stay
Time frame: Within 30 days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No. The NSQIP data is available upon request to investigators at participating sites. We will not directly share our dataset as per the NSQIP Participant Data Use agreement.
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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.
Alana Flexman, MD principal investigator
University of British Columbia
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 Perioperative Complication and Stroke, Acute, run by University of British Columbia 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 2 inclusion and 1 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 30 Jun 2022. 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 Alana Flexman, MD ((604) 806-8337, aflexman@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Within 30 days of surgery). 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 30 Jun 2022.