Thiamine treatment for cognitive issues after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of thiamine intervention on cognitive deficits in patients with coronary heart disease undergoing coronary artery bypass grafting. It employs a double-blind, randomized design with 52 participants divided into two groups: one receiving thiamine and the other a placebo. The study aims to assess cognitive performance and measure blood levels of thiamine, lactate, and inflammatory markers. The goal is to determine if thiamine can mitigate cognitive decline post-surgery, potentially leading to improved quality of life for patients.

Why it matters

Who can join: the full rules

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

Where it's running

• UCLA
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Rajesh Kumar, PhD — University of California, Los Angeles
• Study coordinator: Rajesh Kumar, PhD
• Email: rkumar@mednet.ucla.edu
• Phone: 310-206-1699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.