Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients

March 24, 2023 updated by: Population Health Research Institute

Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients: A Cohort Evaluation Pilot (NeuroVISION Cardiac Pilot)

The investigators conducted a prospective observational pilot study to explore the incidence of peri-operative covert strokes (detected by brain MRI) and the potential impact on delirium and cognitive decline in post-operative cardiac surgery patients at the Hamilton General Hospital. This pilot study assessed the feasibility of a larger prospective international cohort study exploring this objective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Delirium and cognitive decline are common following cardiac surgery and increase the burden on patients and health care resources. Covert (sub-clinical) strokes are associated with these complications. The investigators conducted a prospective cohort pilot study enrolling consecutive cardiac surgery patients to receive a post-operative brain MRI and a series of questionnaires to assess for changes in cognition, physical function and delirium. Regional cerebral oxygen saturation (rSO2) was recorded during surgery with the use of near-infrared spectroscopy (NIRS) sensors placed on the patients' forehead. The primary aim was to determine the feasibility of conducting a larger study to establish an association between covert stroke and long-term cognitive decline in cardiac surgery patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 21 years or more scheduled to undergo isolated coronary artery bypass grafting (CABG) surgery with a median sternotomy and at least one vascular risk factor.

Description

Inclusion Criteria:

  1. Male or female ≥ 21 years old
  2. Provide written informed consent
  3. Scheduled to undergo isolated CABG through a median sternotomy approach

  4. Have at least one of the following risk factors:

    1. Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI <0.9, or previous AAA repair)
    2. Cerebrovascular disease (history of stroke, TIA, or carotid stenosis >70%)
    3. Renal insufficiency (eGFR <60 mL/min/1.73m2)
    4. Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
    5. Urgent CABG (in-patient awaiting revascularization for ACS or MI)
    6. Recent smoker (within the last year)
    7. Left ventricular ejection fraction <35%

Exclusion Criteria:

  1. Concomitant cardiac procedure with CABG Prior enrolment in this study
  2. Emergency CABG surgery (immediate revascularization for hemodynamic instability)
  3. Redo CABG
  4. Circulatory arrest planned during the cardiac operation
  5. Diagnosed dementia of any types
  6. Contra-indication for DW MRI e.g. claustrophobia, unable to lie flat for the duration of the study, pacemaker or ICD in-situ, or other metal implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 30 days
Average recruitment rate per week
30 days
MRI completion
Time Frame: 30 days
Total number of patients completing the brain MRI study
30 days
Lost to follow-up
Time Frame: 3 months
Proportion of patients lost to follow-up at the end of the study
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Covert stroke
Time Frame: 30 days
The proportion of patients experiencing covert stroke within 30 days of surgery
30 days
Clinical stroke
Time Frame: 30 days
The proportion of patients experiencing clinical stroke 30 days after surgery
30 days
Cognitive decline (MoCA)
Time Frame: 30 days
The proportion of patients experiencing cognitive decline 30 days after surgery using the Montreal Cognitive Assessment (MoCA).
30 days
Cognitive decline (DSST)
Time Frame: 30 days
The proportion of patients experiencing cognitive decline 30 days after surgery using the Digit Symbol Substitution Test (DSST).
30 days
Physical function
Time Frame: 3 months
The proportion of patients experiencing cognitive decline 30 days after surgery using the Standard Assessment of Global-activities in the Elderly (SAGE).
3 months
Delirium
Time Frame: day 2 to 30 day, whichever comes first
The proportion of patients experiencing delirium between postoperative day 2 and discharge or 30 days, whichever comes first using the Confusion Assessment Method (CAM).
day 2 to 30 day, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NeuroVISION Cardiac Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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