About this trial
Neurocognitive decline has long been suspected to be a potential long-term complication of coronary artery bypass grafting surgery (CABG), with reports of post-operative cognitive dysfunction by objective testing approaching 15-50% of patients in the year following surgery. To determine the true rate of long-term cognitive dysfunction following CABG compared to percutaneous coronary intervention (PCI or coronary stent placement), we propose a multi-center, two-group, non-randomized study using computer-based customized neurocognitive testing (Cogsate), prior to the procedure and then at 30 days, 1-year and 2-years after revascularization to evaluate cognitive function vital for the maintenance and advancement of professional and personal activities. It is anticipated that the study will document a higher rate of cognitive dysfunction in the CABG group, that the landmark study will provide both the patient and physician with the information necessary to make an informed decision regarding the cognitive risks of CABG versus PCI when faced with the need for coronary revascularization, and that these results will change the clinical practice of recommending CABG as a primary revascularization option for those wishing to preserve cognitive function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Criteria for enrollment are age 18 years or more.
A candidate for either elective single or multi-vessel CABG or PCI without limits for lesion location, lesion characteristics or complexity, the number of vessels treated, or the number of stents or bypass grafts placed, or the type of bypass grafts.
The decision to undergo either CABG or PCI will be made by the treating physician and patient before research study enrollment, and thus, the revascularization decision is not directed by this research protocol.
Disqualifiers
Concomitant valve therapy (surgical or transcatheter).
Prior CABG or surgical valve repair/replacement surgery.
PCI within 1 year of the study entry procedure.
A hybrid revascularization procedure (PCI plus CABG), an untreated carotid artery stenosis of >70%, inability to provide informed consent.
Trial population
The CDAC Study is an observational, two-group, non-randomized cohort of 600 patients undergoing elective CABG or PCI
Trial design
Case-control
Prospective
Treatments tested in this trial
Neurocognitive testing
BehavioralPatients will undergo computer-based customized neurocognitive testing (Cogstate), chosen for its sensitivity to detect cognitive changes in multiple domains.
Treatment groups
Trial outcomes
Primary outcomes
Change in neurocognitive testing
A change of within-patient cumulative Cogstate computer-based neurocognitive test performance.
Secondary outcomes
Change in neurocognitive testing
A change in within-patient neurocognitive test performance at baseline compared to 1-month after revascularization discharge
Change in neurocognitive testing
A change in within-patient neurocognitive test performance at baseline compared to 1-year after revascularization discharge
Incidence of stroke or TIA
Stroke or TIA
New diagnosis of a Mood Disorder
The new diagnosis of a mood or neurodegenerative movement disorder
Locations
Sponsors and contacts
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