Recruiting
Early Phase 1

Thiamine Intervention

Sponsor:

UCLA

Code:

NCT06326996

Conditions

Coronary Heart Disease

Coronary Artery Bypass Grafting

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Thiamine

Placebo

Study Details

Brief summary:

The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects.

Conditions

Coronary Heart Disease

Coronary Artery Bypass Grafting

Study ID

NCT06326996

Start date

Oct 10, 2024

Status verified date

Jul, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with Coronary Heart Disease (CHD) scheduled for Bypass Grafting (CABG)
  • Thiamine deficiency before CABG
  • European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) >1.5%
  • Off-pump surgery

Exclusion Criteria:

  • Dementia at baseline \[Montreal Cognitive Assessment (MoCA) <21 within 5 days before CABG\]
  • Current in-take of thiamine
  • Known thiamine allergy
  • Uncontrolled blood glucose levels
  • Unable to give consent due to illness
  • History of hyperlactatemia
  • Recent (within several years and/or up to the judgment of the PI/co-PIs) cerebral incidents (seizure or head trauma resulting in loss of consciousness and/or concussion)
  • Stroke
  • Diagnosed psychiatric diseases (clinical depression, schizophrenia, manic-depression)
  • Patients with history of alcohol or substance abuse
  • Acute or chronic infections (tuberculosis, hepatitis, or encephalopathy)
  • Diagnosed neuro-degenerative diseases (Alzheimer's or Parkinson's disease)
  • Chronic immunodeficiency (including HIV)
  • Congenital brain deficits will also be excluded

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Post-CABG patients with Thiamine Treatment Intervention.

Assess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving thiamine intervention treatment within 5 days (baseline) and one month after CABG.

placebo comparator: Post-CABG patients without Thiamine Treatment Intervention.

Assess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving placebo treatment within 5 days (baseline) and one month after CABG.

Interventions

Thiamine

Participants will be given an infusion of thiamine.

Placebo

Participants will be given an infusion of the placebo treatment.

Primary outcome measure

  • Effects of thiamine treatment intervention on blood lactate levels. [ Time Frame: Baseline and after 1 month after CABG. ]
  • Effects of thiamine treatment intervention on blood thiamine levels. [ Time Frame: Baseline and after 1 month after CABG. ]
  • Effects of thiamine treatment intervention on blood inflammatory levels. [ Time Frame: Baseline and after 1 month after CABG. ]
  • Evaluate cognitive function in CABG patients with thiamine treatment. [ Time Frame: Baseline and after 1 month after CABG. ]
  • Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment. [ Time Frame: 6 months after CABG. ]
  • Examine cognition in CABG patients with thiamine treatment. [ Time Frame: Baseline and 1 month after CABG. ]
  • Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment. [ Time Frame: 6 months after CABG. ]
  • Cognition assessment in CABG patients after thiamine treatment. [ Time Frame: Baseline and 1 month after CABG. ]
  • Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment. [ Time Frame: 6 months after CABG. ]
  • Long term effect of thiamine treatment intervention on quality of life. [ Time Frame: 6 months after CABG. ]
  • Long term effect of thiamine treatment intervention on daily activities using PASE. [ Time Frame: 6 months after CABG. ]
  • Long term effect of thiamine treatment intervention on daily activities using PPA. [ Time Frame: 6 months after CABG. ]

Central Contacts and Locations

Central contacts

Rajesh Kumar, PhD

310-206-1699rkumar@mednet.ucla.edu

Dineth Karunamuni, MS

856-701-5332dkarunamuni@mednet.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rajesh Kumar, PHD

310-825-1808rkumar@mednet.ucla.edu

Dineth Karunamuni, MS

856-701-5332dkarunamuni@mednet.ucla.edu

Principal Investigator:

Rajesh Kumar, PHD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • thiamine intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-08-03.