Thiamine treatment for cognitive issues after heart surgery
Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.
This study is testing if giving thiamine to patients with heart disease after heart surgery can help improve their thinking and memory skills.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06326996 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 60-80 with coronary heart disease scheduled for bypass grafting and exhibiting thiamine deficiency.
Not a fit: Patients with pre-existing dementia, uncontrolled blood glucose levels, or those currently taking thiamine will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce cognitive deficits in patients after heart surgery, enhancing their quality of life.
How similar studies have performed: While the approach of using thiamine for cognitive protection is innovative, similar studies have shown promising results in other conditions, suggesting potential efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.