Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Effects of thiamine treatment intervention on blood lactate levels.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be assigned a random number, double-blind randomized, & longitudinal study design.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Thiamine (Drug)
结局指标
主要结局
Effects of thiamine treatment intervention on blood lactate levels.
时间窗: Baseline and after 1 month after CABG.
Assess thiamine treatment effect on blood lactate levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).
Evaluate cognitive function in CABG patients with thiamine treatment.
时间窗: Baseline and after 1 month after CABG.
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.
Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.
时间窗: 6 months after CABG.
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.
Long term effect of thiamine treatment intervention on quality of life.
时间窗: 6 months after CABG.
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.
Effects of thiamine treatment intervention on blood inflammatory levels.
时间窗: Baseline and after 1 month after CABG.
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.
Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.
时间窗: 6 months after CABG.
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.
Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.
时间窗: 6 months after CABG.
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.
Examine cognition in CABG patients with thiamine treatment.
时间窗: Baseline and 1 month after CABG.
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.
Effects of thiamine treatment intervention on blood thiamine levels.
时间窗: Baseline and after 1 month after CABG.
Assess thiamine treatment effect on blood thiamine levels in CABG patients with and without intervention measured via blood gas analyzer (ABL90 flex plus, Radiometer).
Cognition assessment in CABG patients after thiamine treatment.
时间窗: Baseline and 1 month after CABG.
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.
Long term effect of thiamine treatment intervention on daily activities using PASE.
时间窗: 6 months after CABG.
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.
Long term effect of thiamine treatment intervention on daily activities using PPA.
时间窗: 6 months after CABG.
Examine the long-term daily activities status in older CHD subjects with and without thiamine intervention treatment as measured by Paffenbarger Physical Activity (PPA).
次要结局
未报告次要终点
研究者
Rajesh Kumar, PhD
Professor of Anesthesiology and Radiological Sciences
University of California, Los Angeles