Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients

Completed

• Conditions: Silent Stroke; Cognitive Decline

• Registration Number: NCT04241289
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study Start: 2017-03-27
• Primary Completion: 2018-06-25
• Study Completion: 2018-09-30
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lost to follow-up	3 months	Proportion of patients lost to follow-up at the end of the study
Recruitment rate	30 days	Average recruitment rate per week
MRI completion	30 days	Total number of patients completing the brain MRI study

Secondary Outcome Measures

Name	Time	Method
Physical function	3 months	The proportion of patients experiencing cognitive decline 30 days after surgery using the Standard Assessment of Global-activities in the Elderly (SAGE).
Covert stroke	30 days	The proportion of patients experiencing covert stroke within 30 days of surgery
Clinical stroke	30 days	The proportion of patients experiencing clinical stroke 30 days after surgery
Cognitive decline (MoCA)	30 days	The proportion of patients experiencing cognitive decline 30 days after surgery using the Montreal Cognitive Assessment (MoCA).
Cognitive decline (DSST)	30 days	The proportion of patients experiencing cognitive decline 30 days after surgery using the Digit Symbol Substitution Test (DSST).
Delirium	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).

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada