Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients: A Cohort Evaluation Pilot (NeuroVISION Cardiac Pilot)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Silent Stroke
- Sponsor
- Population Health Research Institute
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Lost to follow-up
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female ≥ 21 years old
- •Provide written informed consent
- •Scheduled to undergo isolated CABG through a median sternotomy approach
- •Have at least one of the following risk factors:
- •Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI \<0.9, or previous AAA repair)
- •Cerebrovascular disease (history of stroke, TIA, or carotid stenosis \>70%)
- •Renal insufficiency (eGFR \<60 mL/min/1.73m2)
- •Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
- •Urgent CABG (in-patient awaiting revascularization for ACS or MI)
- •Recent smoker (within the last year)
Exclusion Criteria
- •Concomitant cardiac procedure with CABG Prior enrolment in this study
- •Emergency CABG surgery (immediate revascularization for hemodynamic instability)
- •Circulatory arrest planned during the cardiac operation
- •Diagnosed dementia of any types
- •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
Outcomes
Primary Outcomes
Lost to follow-up
Time Frame: 3 months
Proportion of patients lost to follow-up at the end of the study
Recruitment rate
Time Frame: 30 days
Average recruitment rate per week
MRI completion
Time Frame: 30 days
Total number of patients completing the brain MRI study
Secondary Outcomes
- Physical function(3 months)
- Covert stroke(30 days)
- Clinical stroke(30 days)
- Cognitive decline (MoCA)(30 days)
- Cognitive decline (DSST)(30 days)
- Delirium(day 2 to 30 day, whichever comes first)