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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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

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

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

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)

March 27, 2017

Primary Completion (Actual)

June 25, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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