Thiamine Intervention and Coronary Artery Bypass Grafting (B1&CABG)

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Early Phase 1

Conditions: Coronary Heart Disease; Coronary Artery Bypass Grafting

Treatments: Drug: Placebo; Drug: Thiamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06326996

R21AG081720-01A1 (U.S. NIH Grant/Contract)

23-001185

Details and patient eligibility

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

52 participants in 2 patient groups, including a placebo group

Post-CABG patients with Thiamine Treatment Intervention.

Experimental group

Description:

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.

Treatment:

Drug: Thiamine

Post-CABG patients without Thiamine Treatment Intervention.

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo