The CDAC Study - Cerebral Dysfunction After Coronary Revascularization

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Conditions studied: CABG, PCI, Cognitive Decline

In brief

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.

Key facts

Study ID

NCT07491120

Run by

The Scripps Research Institute

People needed

600

Starts

2027-01-01

Expected to finish

2033-01-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients will not be enrolled due to:
• 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.
• The inability to perform pre-procedure tablet-based neurocognitive testing.
• The lack of stated agreement to return for follow-up on-site neurocognitive testing at the prescribed time points.

Full record on ClinicalTrials.gov

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