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 range21 Years

SexALL

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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)
✓. 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

What they're measuring

Recruitment rate

Timeframe: 30 days

MRI completion

Timeframe: 30 days

Lost to follow-up

Timeframe: 3 months

Trial details

NCT IDNCT04241289

SponsorPopulation Health Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06-25

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