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

March 28, 2024 updated by: Rajesh Kumar, PhD, University of California, Los Angeles

Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Thiamine
Participants will be given an infusion of thiamine.
Other Names:
  • Vitamin B1
Placebo Comparator: 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.
Other: Placebo
Participants will be given an infusion of the placebo treatment.
Other Names:
  • inactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of thiamine treatment intervention on blood lactate levels.
Time Frame: 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).
Baseline and after 1 month after CABG.
Effects of thiamine treatment intervention on blood thiamine levels.
Time Frame: 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).
Baseline and after 1 month after CABG.
Effects of thiamine treatment intervention on blood inflammatory levels.
Time Frame: 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.
Baseline and after 1 month after CABG.
Long term effect of thiamine treatment intervention on daily activities using PPA.
Time Frame: 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).
6 months after CABG.
Evaluate cognitive function in CABG patients with thiamine treatment.
Time Frame: 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.
Baseline and after 1 month after CABG.
Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.
Time Frame: 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.
6 months after CABG.
Examine cognition in CABG patients with thiamine treatment.
Time Frame: 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.
Baseline and 1 month after CABG.
Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.
Time Frame: 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.
6 months after CABG.
Cognition assessment in CABG patients after thiamine treatment.
Time Frame: 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.
Baseline and 1 month after CABG.
Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.
Time Frame: 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.
6 months after CABG.
Long term effect of thiamine treatment intervention on quality of life.
Time Frame: 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.
6 months after CABG.
Long term effect of thiamine treatment intervention on daily activities using PASE.
Time Frame: 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.
6 months after CABG.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Rajesh Kumar, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-001185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Once the findings have been published or by the end of award performance period, whichever is sooner.

IPD Sharing Access Criteria

Any research investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Heart Disease

Clinical Trials on Thiamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe