Summary

Eligibility
for people ages 60-80 (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Rajesh Kumar, PhD

Description

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.

Official Title

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

Details

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.

Keywords

Coronary Heart Disease, Coronary Artery Bypass Grafting, thiamine intervention, Heart Diseases, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia, Thiamine

Eligibility

You can join if…

Open to people ages 60-80

  • 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 CAN'T join 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

Location

  • UCLA accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Rajesh Kumar, PhD
    Professor-in-Residence, Anesthesiology, Medicine. Authored (or co-authored) 101 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06326996
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 52 study participants
Last Updated