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Recruiting NCT06326996

Thiamine Intervention and Coronary Artery Bypass Grafting

Early Phase I Interventional Coronary Heart Disease Coronary Artery Bypass Grafting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thiamine, Placebo.
Who it may be relevant to
Registry conditions: Coronary Heart Disease, Coronary Artery Bypass Grafting. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Thiamine
    Participants will be given an infusion of thiamine.
  • Drug Placebo
    Participants will be given an infusion of the placebo treatment.

Primary outcome measures

  • Effects of thiamine treatment intervention on blood lactate levels. [Time frame: 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.]
  • Effects of thiamine treatment intervention on blood inflammatory levels. [Time frame: Baseline and after 1 month after CABG.]
  • Evaluate cognitive function in CABG patients with thiamine treatment. [Time frame: 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.]
  • Examine cognition in CABG patients with thiamine treatment. [Time frame: 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.]
  • Cognition assessment in CABG patients after thiamine treatment. [Time frame: 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.]
  • Long term effect of thiamine treatment intervention on quality of life. [Time frame: 6 months after CABG.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCLA — Los Angeles

Publications

  • Gershon RC, Wagster MV, Hendrie HC, Fox NA, Cook KF, Nowinski CJ. NIH toolbox for assessment of neurological and behavioral function. Neurology. 2013 Mar 12;80(11 Suppl 3):S2-6. doi: 10.1212/WNL.0b013e3182872e5f. PMID 23479538
  • Hodes RJ, Insel TR, Landis SC; NIH Blueprint for Neuroscience Research. The NIH toolbox: setting a standard for biomedical research. Neurology. 2013 Mar 12;80(11 Suppl 3):S1. doi: 10.1212/WNL.0b013e3182872e90. PMID 23479536
  • Sheslow DA, W. . Wide range assessment of memory and learning (2nd edition) administration and technical manual In: Editor, ed.^eds. Wide range assessment of memory and learning (2nd edition) administration and technical manual. City: Psychological Assessment Resources, 2003.
  • Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WN PMID 23479546
  • Ware J, Kosinski M, Dewey JE. How to score version 2 of the SF- 36 health survey. Lincoln, RI: QualityMetric Incorporated; 2000 p 229: 2000.
  • Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4. PMID 8437031
  • Bolszak S, Casartelli NC, Impellizzeri FM, Maffiuletti NA. Validity and reproducibility of the Physical Activity Scale for the Elderly (PASE) questionnaire for the measurement of the physical activity level in patients after total knee arthroplasty. BMC Musculoskelet Disord. 2014 Feb 20;15:46. doi: 10.1186/1471-2474-15-46. PMID 24555852
  • Paffenbarger RS Jr, Wing AL, Hyde RT. Physical activity as an index of heart attack risk in college alumni. Am J Epidemiol. 1978 Sep;108(3):161-75. doi: 10.1093/oxfordjournals.aje.a112608. PMID 707484

Identifiers

NCT: NCT06326996 · 23-001185 · R21AG081720-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗