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Thiamine Intervention and Coronary Artery Bypass Grafting
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.
Conditions:
🦠 Coronary Heart Disease 🦠 Coronary Artery Bypass Grafting
🗓️ Study Start (Actual) May 2024
🗓️ Primary Completion (Estimated) January 2026
✅ Study Completion (Estimated) May 2026
👥 Enrollment (Estimated) 52
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 60 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 March 2024
  • First Submitted that Met QC Criteria 20 March 2024
  • First Posted 25 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024
I'm interested ...!!