Thiamine Intervention for Coronary Artery Bypass Grafting
This study is looking at whether giving thiamine (a type of vitamin B1) can help reduce thinking and memory problems after coronary artery bypass grafting (CABG) surgery. You might be able to join if you have coronary heart disease (CHD), are scheduled for CABG, are between 60 and 80 years old, have a thiamine deficiency, and meet other criteria. Participants will receive either an infusion of thiamine or a placebo (an inactive substance). Researchers will measure your blood levels of thiamine, lactate, and inflammation to see if thiamine helps. The study's status is currently unclear.
- Study design
- This is a double-blind, randomized study with two groups, involving 52 participants. This means neither you nor the study team will know if you are receiving thiamine or the placebo.
- What's involved
- You will undergo cognitive assessments and have your blood levels of thiamine, lactate, and inflammatory markers evaluated at the beginning of the study and one month after your CABG surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood levels will be measured at baseline and again one month after your CABG surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Thiamine Intervention and Coronary Artery Bypass Grafting
At a glance
Conditions
NCT06326996
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
UCLA
Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Rajesh Kumar, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
Who to contact
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Inclusion
Exclusion
What this trial measures
- Effects of thiamine treatment intervention on blood lactate levels.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.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.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.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.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.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.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.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.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.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.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.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).