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Thiamine Intervention and Coronary Artery Bypass Grafting

RECRUITINGEarly 1Sponsored by University of California, Los Angeles
Actively Recruiting
PhaseEarly 1
SponsorUniversity of California, Los Angeles
Started2024-10-10
Est. completion2026-06-30
Eligibility
Age60 Years – 80 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06326996

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

Age: 60 Years – 80 YearsHealthy volunteers accepted
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

Conditions3

Coronary Artery Bypass GraftingCoronary Heart DiseaseHeart Disease

Locations1 site

UCLA
Los Angeles, California, 90095
Rajesh Kumar, PHD310-825-1808rkumar@mednet.ucla.edu

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