NCT06326996 Thiamine Intervention and Coronary Artery Bypass Grafting
| NCT ID | NCT06326996 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Los Angeles |
| Condition | Coronary Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2024-10-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Rajesh Kumar, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06326996 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 80 Years, studying Coronary Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06326996 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06326996 currently recruiting?
Yes, NCT06326996 is actively recruiting participants. Contact the research team at rkumar@mednet.ucla.edu for enrollment information.
Where is the NCT06326996 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06326996 clinical trial?
NCT06326996 is sponsored by University of California, Los Angeles. The principal investigator is Rajesh Kumar, PhD at University of California, Los Angeles. The trial plans to enroll 52 participants.