Thiamine Intervention and Coronary Artery Bypass Grafting

NCT ID: NCT06326996

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2026-09-30

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.

Conditions

Coronary Heart Disease; Coronary Artery Bypass Grafting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Post-CABG patients with Thiamine Treatment Intervention.

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.

Group Type: EXPERIMENTAL

Thiamine

Intervention Type: DRUG

Participants will be given an infusion of thiamine.

Post-CABG patients without Thiamine Treatment Intervention.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will be given an infusion of the placebo treatment.

Interventions

Thiamine

Participants will be given an infusion of thiamine.

Intervention Type: DRUG

Placebo

Participants will be given an infusion of the placebo treatment.

Intervention Type: DRUG

Other Intervention Names

Vitamin B1; inactive

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Rajesh Kumar, PhD

Professor of Anesthesiology and Radiological Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajesh Kumar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rajesh Kumar, PhD

Role: CONTACT

rkumar@mednet.ucla.edu

310-206-1699

Dineth Karunamuni, MS

Role: CONTACT

dkarunamuni@mednet.ucla.edu

856-701-5332

Facility Contacts

Rajesh Kumar, PHD

Role: primary

rkumar@mednet.ucla.edu

310-825-1808

Dineth Karunamuni, MS

Role: backup

dkarunamuni@mednet.ucla.edu

856-701-5332

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Other Identifiers

R21AG081720-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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23-001185

Identifier Type: -

Identifier Source: org_study_id