NCT06326996

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for early_phase_1

Timeline
5mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

March 7, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

March 7, 2024

Last Update Submit

July 30, 2025

Conditions

Coronary Heart DiseaseCoronary Artery Bypass Grafting

Keywords

thiamine intervention

Outcome Measures

Primary Outcomes (12)

  • Effects of thiamine treatment intervention on blood lactate levels.

    Assess thiamine treatment effect on blood lactate levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).

    Baseline and after 1 month after CABG.

  • Effects of thiamine treatment intervention on blood thiamine levels.

    Assess thiamine treatment effect on blood thiamine levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).

    Baseline and after 1 month after CABG.

  • Effects of thiamine treatment intervention on blood inflammatory levels.

    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.

    Baseline and after 1 month after CABG.

  • Evaluate cognitive function in CABG patients with thiamine treatment.

    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.

    Baseline and after 1 month after CABG.

  • Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.

    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.

    6 months after CABG.

  • Examine cognition in CABG patients with thiamine treatment.

    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.

    Baseline and 1 month after CABG.

  • Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.

    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.

    6 months after CABG.

  • Cognition assessment in CABG patients after thiamine treatment.

    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.

    Baseline and 1 month after CABG.

  • Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.

    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.

    6 months after CABG.

  • Long term effect of thiamine treatment intervention on quality of life.

    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.

    6 months after CABG.

  • Long term effect of thiamine treatment intervention on daily activities using PASE.

    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.

    6 months after CABG.

  • Long term effect of thiamine treatment intervention on daily activities using PPA.

    Examine the long-term daily activities status in older CHD subjects with and without thiamine intervention treatment as measured by Paffenbarger Physical Activity (PPA).

    6 months after CABG.

Study Arms (2)

Post-CABG patients with Thiamine Treatment Intervention.

EXPERIMENTAL

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.

Drug: Thiamine

Post-CABG patients without Thiamine Treatment Intervention.

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ThiamineDRUG

Participants will be given an infusion of thiamine.

Also known as: Vitamin B1
Post-CABG patients with Thiamine Treatment Intervention.
PlaceboDRUG

Participants will be given an infusion of the placebo treatment.

Also known as: inactive
Post-CABG patients without Thiamine Treatment Intervention.

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (128)

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MeSH Terms

Conditions

Coronary Disease

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Rajesh Kumar, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Kumar, PhD

CONTACT

310-206-1699rkumar@mednet.ucla.edu

Dineth Karunamuni, MS

CONTACT

856-701-5332dkarunamuni@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be assigned a random number, double-blind randomized, \& longitudinal study design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Post-CABG patients with and without thiamine treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology and Radiological Sciences

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 25, 2024

Study Start

October 10, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The investigators will make every effort to publish data in a timely manner. Once the findings related to changes in blood lactate, thiamine, and inflammatory levels based on blood pathology and cognition assessment data before and after thiamine intervention on CHD subjects before and after CABG have been published or by the end of award performance period, whichever is sooner, the blood levels, cognitive data, demographics, mood, and clinical data (devoid of individual identifiers) will be deposited in NIH supported domain-specific data sharing repository (NIMH Data Archive). All data will be labeled with consistent unique identifiers that will make it easily findable in data repository to interested research investigators. Data will be available forever after sharing with data repository to other investigators for secondary analyses.

Time Frame
Once the findings have been published or by the end of award performance period, whichever is sooner.
Access Criteria
Any research investigator

Locations

US(1)