NCT06326996 · University of California, Los Angeles
Thiamine Intervention and Coronary Artery Bypass Grafting
(B1&CABG)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Thiamine
Participants will be given an infusion of thiamine.
DRUG
Placebo
Participants will be given an infusion of the placebo treatment.
Primary outcome measures
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Los Angeles, California
Collaborators
National Institute on Aging (NIA)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations