Recruiting

Observational Study

Sponsor:

Dr. Gordon Boyd

Code:

NCT04081649

Conditions

Coronary Artery Disease

Cognitive Impairment

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The overall goal of this research program is to determine quantitative predictors of quantitative long-term neurological functioning following different cardiac surgery procedures. The investigators aim to generate a timeline of neurological function that includes pre-existing performance, post-operative delirium, and neurological outcome. Furthermore, the investigators will test the hypothesis that intraoperative regional cerebral oxygenation (rSO2) desaturations, as measured by near-infrared spectroscopy (NIRS) are associated with poor neurological functioning following cardiac surgery, as measured by a robotic device called the KINARM.

Conditions

Coronary Artery Disease

Cognitive Impairment

Delirium

Study ID

NCT04081649

Start date

Jun 1, 2014

Status verified date

Dec, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult patients undergoing coronary artery bypass surgery +/- valvular surgery

Exclusion Criteria:

  • pre-existing cognitive impairment or neurodegenerative condition
  • any reason that participant cannot participate in follow up (lives too far away, limb amputation, speaks language other than english)

Study Design

Enrollment

95 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac surgery

Patients undergoing non-emergent cardiac surgery for coronary bypass graft and/or valvular replacement

Primary outcome measure

  • 12 month cognitive outcome-Repeatable Battery of Neuropsychological Status (RBANS) Total Scale [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-visually guided reaching [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-arm position matching [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-reverse visually guided reaching [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-ball on bar [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-object hit [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-object hit and avoid [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-spatial span [ Time Frame: 12 months ]
  • 12 month cognitive outcome-KINARM robotic assessment-trail making [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

J. Gordon Boyd, MD, PhD

61353927542jgb1@queensu.ca

Locations

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L3V7

Contacts

John G Boyd, MD, PhD

613-549-66662jgb1@queensu.ca

More Information

Sponsor

Dr. Gordon Boyd

Last update posted

Dec 26, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Gordon Boyd on 2023-12-26.