NCT07491120

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
73mo left

Started Jan 2027

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

March 16, 2026

Last Update Submit

March 19, 2026

Conditions

CABGPCICognitive Decline

Keywords

CABGPCICognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Change in neurocognitive testing

    A change of within-patient cumulative Cogstate computer-based neurocognitive test performance.

    2 years

Secondary Outcomes (10)

  • Change in neurocognitive testing

    1 month

  • Change in neurocognitive testing

    1 year

  • Incidence of stroke or TIA

    2 years

  • New diagnosis of a Mood Disorder

    2 years

  • The new need for Psychiatry

    2 years

  • +5 more secondary outcomes

Interventions

Neurocognitive testingBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The CDAC Study is an observational, two-group, non-randomized cohort of 600 patients undergoing elective CABG or PCI

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Robert Russo

CONTACT

8587842211Russo@scripps.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 24, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2033

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL