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Thiamine Intervention and Coronary Artery Bypass Grafting

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Early Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
60 Years
Maximum Age
80 Years

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

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Study Stats
Protocol No.
23-001185
Category
Heart/Cardiovascular Diseases
Principal Investigator
Rajesh Kumar
Contact
Dineth Karunamuni
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06326996
For detailed technical eligibility, visit ClinicalTrials.gov.