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RecruitingNCT06326996B1&CABGUpdated Aug 3, 2026

Thiamine Intervention and Coronary Artery Bypass Grafting

An Early Phase 1 interventional study of Thiamine and Placebo in Coronary Heart Disease and Coronary Artery Bypass Grafting, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by University of California, Los Angeles · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Using a two-group, double-blind randomized, longitudinal study design, 52 coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) (ages 60-80 years; 26 thiamine treatment and 26 placebo) will participate in cognitive assessment and evaluation of blood thiamine, lactate, and inflammatory marker levels. The investigators propose that thiamine infusion will help in reducing lactate and inflammatory marker levels, as observed in other conditions. The findings from this study might serve as a novel and innovative treatment strategy for protection against declining cognition, and hence better outcomes, and improved quality of life and daily activities. This clinical trial study will provide required data regarding the benefits of a low-cost thiamine intervention that could be implemented on a large-scale clinical trial to reduce post-CABG cognitive deficits in older CHD, and thus, decrease early dementia, improve social function, increase quality of life and daily activities, and reduce healthcare costs in this serious older CHD patient population.

02

Conditions studied

  • Coronary Heart Disease
  • Coronary Artery Bypass Grafting

Browse trials for

Keywords

  • thiamine intervention
03

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's planned enrollment of 52 is below the median of 124 across 1,583 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (estimated)

Study 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.

    Drug: Thiamine

  • 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.

    Drug: Placebo

Interventions

  • DrugThiamine

    Participants will be given an infusion of thiamine.

    Also known as: Vitamin B1

  • DrugPlacebo

    Participants will be given an infusion of the placebo treatment.

    Also known as: inactive

06

What researchers measure

Primary outcomes

  1. Effects of thiamine treatment intervention on blood lactate levels.

    Assess thiamine treatment effect on blood lactate levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).

    Time frame: Baseline and after 1 month after CABG.

  2. Effects of thiamine treatment intervention on blood thiamine levels.

    Assess thiamine treatment effect on blood thiamine levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).

    Time frame: Baseline and after 1 month after CABG.

  3. Effects of thiamine treatment intervention on blood inflammatory levels.

    Assess thiamine treatment effect on blood inflammatory levels in CABG patients with and without intervention measured via a custom kit, including cytokines from the human 38-plex magnetic cytokine/chemokine kit, will be used per manufacturer's instructions.

    Time frame: Baseline and after 1 month after CABG.

  4. Evaluate cognitive function in CABG patients with thiamine treatment.

    The investigators will evaluate cognitive function using the NIH Toolbox Cognition Battery (executive function, attention, and speed). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.

    Time frame: Baseline and after 1 month after CABG.

  5. Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.

    The investigators will evaluate cognitive function using the NIH Toolbox Cognition Battery (executive function, attention, and speed). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.

    Time frame: 6 months after CABG.

  6. Examine cognition in CABG patients with thiamine treatment.

    The investigators will examine cognition using the Wide Range Assessment of Memory and Learning 2 (WRAML2). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.

    Time frame: Baseline and 1 month after CABG.

  7. Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.

    The investigators will examine cognition using the Wide Range Assessment of Memory and Learning 2 (WRAML2). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.

    Time frame: 6 months after CABG.

  8. Cognition assessment in CABG patients after thiamine treatment.

    The investigators will assess cognition using the Montreal Cognitive Assessment (MoCA). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment. The MoCA is a brief cognitive assessment administered to the participant by the investigator. The score ranges from 0 to 30, with higher scores indicating better cognitive function.

    Time frame: Baseline and 1 month after CABG.

  9. Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.

    The investigators will assess cognition using the Montreal Cognitive Assessment (MoCA). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment. The MoCA is a brief cognitive assessment administered to the participant by the investigator. The score ranges from 0 to 30, with higher scores indicating better cognitive function.

    Time frame: 6 months after CABG.

  10. Long term effect of thiamine treatment intervention on quality of life.

    Examine the long-term quality of life in older CHD subjects with and without thiamine intervention treatment as measured by NIH validated Short-Form 36 (SF-36) survey. The SF-36 is a 36 question form filled out by the participant and scored by the investigator. The score ranges from 0 to 100, with higher scores indicating better health status.

    Time frame: 6 months after CABG.

  11. Long term effect of thiamine treatment intervention on daily activities using PASE.

    Examine the long-term daily activities status in older CHD subjects with and without thiamine intervention treatment as measured by NIH validated Physical Activity Scale for the Elderly (PASE). PASE is a brief self-administered questionnaire measuring physical activity which generates a score, ranging from 0 to 793, with higher scores indicating greater physical activity.

    Time frame: 6 months after CABG.

  12. Long term effect of thiamine treatment intervention on daily activities using PPA.

    Examine the long-term daily activities status in older CHD subjects with and without thiamine intervention treatment as measured by Paffenbarger Physical Activity (PPA).

    Time frame: 6 months after CABG.

07

Study locations

1 of 1 sites recruiting
  • UCLA
    Los Angeles, California 90095, United States
    Recruiting
08

References and documents

Publications

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Individual participant data

Plan to share: Yes — The investigators will make every effort to publish data in a timely manner. Once the findings related to changes in blood lactate, thiamine, and inflammatory levels based on blood pathology and cognition assessment data before and after thiamine intervention on CHD subjects before and after CABG have been published or by the end of award performance period, whichever is sooner, the blood levels, cognitive data, demographics, mood, and clinical data (devoid of individual identifiers) will be deposited in NIH supported domain-specific data sharing repository (NIMH Data Archive). All data will be labeled with consistent unique identifiers that will make it easily findable in data repository to interested research investigators. Data will be available forever after sharing with data repository to other investigators for secondary analyses.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06326996
Lead sponsor
University of California, Los Angeles
Collaborators
National Institute on Aging (NIA)
Responsible party
Rajesh Kumar, PhD (Professor of Anesthesiology and Radiological Sciences, University of California, Los Angeles) — Principal investigator
First posted
Mar 25, 2024
Start date
Oct 10, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 3, 2026

Study contacts

Rajesh Kumar, PhD
Contact
rkumar@mednet.ucla.edu
310-206-1699
Dineth Karunamuni, MS
Contact
dkarunamuni@mednet.ucla.edu
856-701-5332
Rajesh Kumar, PhD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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