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NCT Number: NCT06326996

Thiamine Intervention and Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Artery Bypass Grafting Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamine

Drug

Participants will be given an infusion of thiamine.

Other names: Vitamin B1

Placebo

Drug

Participants will be given an infusion of the placebo treatment.

Other names: inactive

Primary outcomes

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

    Time frame: Baseline and after 1 month after CABG.

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

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

    Time frame: Baseline and after 1 month after CABG.

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

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

    Time frame: Baseline and after 1 month after CABG.

    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.

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

    Time frame: Baseline and after 1 month after CABG.

    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.

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

    Time frame: 6 months after CABG.

    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.

  6. Examine cognition in CABG patients with thiamine treatment.

    Time frame: Baseline and 1 month after CABG.

    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.

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

    Time frame: 6 months after CABG.

    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.

  8. Cognition assessment in CABG patients after thiamine treatment.

    Time frame: Baseline and 1 month after CABG.

    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.

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

    Time frame: 6 months after CABG.

    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.

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

    Time frame: 6 months after CABG.

    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.

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

    Time frame: 6 months after CABG.

    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.

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

    Time frame: 6 months after CABG.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dineth Karunamuni, MS

CONTACT

[email protected]

856-701-5332

Rajesh Kumar, PhD

CONTACT

[email protected]

310-206-1699

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.

Acronym: B1&CABG

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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