Thiamine Intervention and Coronary Artery Bypass Grafting

Coronary Heart Disease Clinical Trial

— B1&CABG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326996
• Other study ID #: 23-001185
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: Rajesh Kumar, PhD
• Phone: 310-206-1699
• Email: rkumar[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: May 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Unable to give consent due to illness
• History of hyperlactatemia
• 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)
• Stroke
• Diagnosed psychiatric diseases (clinical depression, schizophrenia, manic-depression)
• Patients with history of alcohol or substance abuse
• Acute or chronic infections (tuberculosis, hepatitis, or encephalopathy)
• Diagnosed neuro-degenerative diseases (Alzheimer's or Parkinson's disease)
• Chronic immunodeficiency (including HIV)
• Congenital brain deficits will also be excluded

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Thiamine
Participants will be given an infusion of thiamine.

Other:
• Placebo
Participants will be given an infusion of the placebo treatment.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (128)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and after 1 month after CABG.
Primary	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).	Baseline and after 1 month after CABG.
Primary	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.	Baseline and after 1 month after CABG.
Primary	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.	Baseline and after 1 month after CABG.
Primary	Evaluate long term effects of thiamine treatment intervention on 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.	6 months after CABG.
Primary	Examine cognition in CABG patients with thiamine treatment.	The investigators will examine cognition using the Wide Range Assessment of Memory and Learning 2 (WRAML2). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.	Baseline and 1 month after CABG.
Primary	Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.	The investigators will examine cognition using the Wide Range Assessment of Memory and Learning 2 (WRAML2). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment.	6 months after CABG.
Primary	Cognition assessment in CABG patients after thiamine treatment.	The investigators will assess cognition using the Montreal Cognitive Assessment (MoCA). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment. The MoCA is a brief cognitive assessment administered to the participant by the investigator. The score ranges from 0 to 30, with higher scores indicating better cognitive function.	Baseline and 1 month after CABG.
Primary	Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.	The investigators will assess cognition using the Montreal Cognitive Assessment (MoCA). CABG patients with thiamine treatment will show a change in cognition over CABG patients without thiamine treatment. The MoCA is a brief cognitive assessment administered to the participant by the investigator. The score ranges from 0 to 30, with higher scores indicating better cognitive function.	6 months after CABG.
Primary	Long term effect of thiamine treatment intervention on quality of life.	Examine the long-term quality of life in older CHD subjects with and without thiamine intervention treatment as measured by NIH validated Short-Form 36 (SF-36) survey. The SF-36 is a 36 question form filled out by the participant and scored by the investigator. The score ranges from 0 to 100, with higher scores indicating better health status.	6 months after CABG.
Primary	Long term effect of thiamine treatment intervention on daily activities using PASE.	Examine the long-term daily activities status in older CHD subjects with and without thiamine intervention treatment as measured by NIH validated Physical Activity Scale for the Elderly (PASE). PASE is a brief self-administered questionnaire measuring physical activity which generates a score, ranging from 0 to 793, with higher scores indicating greater physical activity.	6 months after CABG.
Primary	Long term effect of thiamine treatment intervention on daily activities using PPA.	Examine the long-term daily activities status in older CHD subjects with and without thiamine intervention treatment as measured by Paffenbarger Physical Activity (PPA).	6 months after CABG.