NCT06326996

Thiamine Intervention and Coronary Artery Bypass Grafting

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Using a two-group, double-blind randomized, longitudinal study design, 52 coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) (ages 60-80 years; 26 thiamine treatment and 26 placebo) will participate in cognitive assessment and evaluation of blood thiamine, lactate, and inflammatory marker levels. The investigators propose that thiamine infusion will help in reducing lactate and inflammatory marker levels, as observed in other conditions. The findings from this study might serve as a novel and innovative treatment strategy for protection against declining cognition, and hence better outcomes, and improved quality of life and daily activities. This clinical trial study will provide required data regarding the benefits of a low-cost thiamine intervention that could be implemented on a large-scale clinical trial to reduce post-CABG cognitive deficits in older CHD, and thus, decrease early dementia, improve social function, increase quality of life and daily activities, and reduce healthcare costs in this serious older CHD patient population.

Conditions

• Coronary Heart Disease
• Coronary Artery Bypass Grafting

Interventions

Type	Name	Description
DRUG	Thiamine	Participants will be given an infusion of thiamine.
DRUG	Placebo	Participants will be given an infusion of the placebo treatment.

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2024-03-25
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study