Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
California
UCLA
RECRUITING
Los Angeles
Contact Information
Primary
Rajesh Kumar, PhD
rkumar@mednet.ucla.edu
310-206-1699
Backup
Dineth Karunamuni, MS
dkarunamuni@mednet.ucla.edu
856-701-5332
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 52
Treatments
Experimental: Post-CABG patients with Thiamine Treatment Intervention.
Assess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving thiamine intervention treatment within 5 days (baseline) and one month after CABG.
Placebo_comparator: Post-CABG patients without Thiamine Treatment Intervention.
Assess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving placebo treatment within 5 days (baseline) and one month after CABG.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: National Institute on Aging (NIA)