Clinical trial NCT06326996: Thiamine Intervention and Coronary Artery Bypass Grafting
Official title: Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Coronary Heart Disease
Coronary Artery Bypass Grafting
Keywords: thiamine intervention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-03-25
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post-CABG patients with and without thiamine treatment.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of thiamine treatment intervention on blood lactate levels.
timeFrame: Baseline and after 1 month after CABG.
measure: Effects of thiamine treatment intervention on blood thiamine levels.
timeFrame: Baseline and after 1 month after CABG.
measure: Effects of thiamine treatment intervention on blood inflammatory levels.
timeFrame: Baseline and after 1 month after CABG.
measure: Evaluate cognitive function in CABG patients with thiamine treatment.
timeFrame: Baseline and after 1 month after CABG.
measure: Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.
timeFrame: 6 months after CABG.
measure: Examine cognition in CABG patients with thiamine treatment.
timeFrame: Baseline and 1 month after CABG.
measure: Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.
timeFrame: 6 months after CABG.
measure: Cognition assessment in CABG patients after thiamine treatment.
timeFrame: Baseline and 1 month after CABG.
measure: Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.
timeFrame: 6 months after CABG.
measure: Long term effect of thiamine treatment intervention on quality of life.
timeFrame: 6 months after CABG.
measure: Long term effect of thiamine treatment intervention on daily activities using PASE.
timeFrame: 6 months after CABG.
measure: Long term effect of thiamine treatment intervention on daily activities using PPA.
timeFrame: 6 months after CABG.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rajesh Kumar, PhD
role: PRINCIPAL_INVESTIGATOR
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