RecruitingEarly Phase 1NCT06326996

Thiamine Intervention and Coronary Artery Bypass Grafting

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


Sponsor

University of California, Los Angeles

Enrollment

52 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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

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Interventions

DRUGThiamine

Participants will be given an infusion of thiamine.

DRUGPlacebo

Participants will be given an infusion of the placebo treatment.


Locations(1)

UCLA

Los Angeles, California, United States

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NCT06326996


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