Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients (NCT04241289) | Clinical Trial Compass
CompletedNot Applicable
Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients
Canada66 participantsStarted 2017-03-27
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
Exclusion criteria
. Concomitant cardiac procedure with CABG Prior enrolment in this study
. Emergency CABG surgery (immediate revascularization for hemodynamic instability)
. Redo CABG
. 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