RECRUITING

Thiamine Intervention and Coronary Artery Bypass Grafting

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - a Randomized Clinical Trial.

Quick Facts

Study Start:2024-10-10
Study Completion:2025-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06326996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with Coronary Heart Disease (CHD) scheduled for Bypass Grafting (CABG)
  2. * Thiamine deficiency before CABG
  3. * European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) \>1.5%
  4. * Off-pump surgery
  1. * Dementia at baseline \[Montreal Cognitive Assessment (MoCA) \<21 within 5 days before CABG\]
  2. * Current in-take of thiamine
  3. * Known thiamine allergy
  4. * Uncontrolled blood glucose levels
  5. * Unable to give consent due to illness
  6. * History of hyperlactatemia
  7. * 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)
  8. * Stroke
  9. * Diagnosed psychiatric diseases (clinical depression, schizophrenia, manic-depression)
  10. * Patients with history of alcohol or substance abuse
  11. * Acute or chronic infections (tuberculosis, hepatitis, or encephalopathy)
  12. * Diagnosed neuro-degenerative diseases (Alzheimer's or Parkinson's disease)
  13. * Chronic immunodeficiency (including HIV)
  14. * Congenital brain deficits will also be excluded

Contacts and Locations

Study Contact

Rajesh Kumar, PhD
CONTACT
310-206-1699
rkumar@mednet.ucla.edu
Bhaswati Roy, PhD
CONTACT
310-206-6133
broy@mednet.ucla.edu

Principal Investigator

Rajesh Kumar, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Rajesh Kumar, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

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

Study Start Date2024-10-10
Study Completion Date2025-09-29

Study Record Updates

Study Start Date2024-10-10
Study Completion Date2025-09-29

Terms related to this study

Keywords Provided by Researchers

  • thiamine intervention

Additional Relevant MeSH Terms

  • Coronary Heart Disease
  • Coronary Artery Bypass Grafting