Thiamine Intervention and Coronary Artery Bypass Grafting
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversity of California, Los Angeles
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Thiamine
DrugParticipants will be given an infusion of thiamine.
Placebo
DrugParticipants will be given an infusion of the placebo treatment.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Post-CABG patients with Thiamine Treatment Intervention.Experimental treatment 1 intervention
Group B: Post-CABG patients without Thiamine Treatment Intervention.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effects of thiamine treatment intervention on blood lactate levels.
Assess thiamine treatment effect on blood lactate levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).
Time frame
Baseline and after 1 month after CABG.2
Effects of thiamine treatment intervention on blood thiamine levels.
Assess thiamine treatment effect on blood thiamine levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).
Time frame
Baseline and after 1 month after CABG.3
Effects of thiamine treatment intervention on blood inflammatory levels.
Assess thiamine treatment effect on blood inflammatory levels in CABG patients with and without intervention measured via a custom kit, including cytokines from the human 38-plex magnetic cytokine/chemokine kit, will be used per manufacturer's instructions.
Time frame
Baseline and after 1 month after CABG.4
Evaluate cognitive function in CABG patients with thiamine treatment.
The investigators will evaluate cognitive function using the NIH Toolbox Cognition Battery (executive function, attention, and speed). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.
Time frame
Baseline and after 1 month after CABG.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov