The CDAC Study - Cerebral Dysfunction After Coronary Revascularization

Sponsor
The Scripps Research Institute
Study ID
NCT07491120
Status
Not Yet Recruiting

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Conditions

  • CABG
  • Cognitive Decline
  • PCI

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurocognitive testing — BEHAVIORAL
    Patients will undergo computer-based customized neurocognitive testing (Cogstate), chosen for its sensitivity to detect cognitive changes in multiple domains.

Study Details

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 Dates

First listed
Mar 24, 2026
Start date
Jan 1, 2027
Status verified
Mar 2026
Primary completion
Jan 1, 2032
Completion
Jan 1, 2033

Study Design

Enrollment
600 participants (estimated)

Primary Outcome Measure

Change in neurocognitive testing [ Time Frame: 2 years ]

Central Contacts

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