Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326996
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-07
Brief Title:
Thiamine Intervention and Coronary Artery Bypass Grafting
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B1CABG
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None