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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG081720-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-CABG patients with Thiamine Treatment Intervention. | Experimental | 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. |
|
| Post-CABG patients without Thiamine Treatment Intervention. | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiamine | Drug | Participants will be given an infusion of thiamine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Kumar, PhD | Contact | 310-206-1699 | rkumar@mednet.ucla.edu | |
| Dineth Karunamuni, MS | Contact | 856-701-5332 | dkarunamuni@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rajesh Kumar, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23479538 | Background | Gershon RC, Wagster MV, Hendrie HC, Fox NA, Cook KF, Nowinski CJ. NIH toolbox for assessment of neurological and behavioral function. Neurology. 2013 Mar 12;80(11 Suppl 3):S2-6. doi: 10.1212/WNL.0b013e3182872e5f. | |
| 23479536 | Background | Hodes RJ, Insel TR, Landis SC; NIH Blueprint for Neuroscience Research. The NIH toolbox: setting a standard for biomedical research. Neurology. 2013 Mar 12;80(11 Suppl 3):S1. doi: 10.1212/WNL.0b013e3182872e90. |
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The investigators will make every effort to publish data in a timely manner. Once the findings related to changes in blood lactate, thiamine, and inflammatory levels based on blood pathology and cognition assessment data before and after thiamine intervention on CHD subjects before and after CABG have been published or by the end of award performance period, whichever is sooner, the blood levels, cognitive data, demographics, mood, and clinical data (devoid of individual identifiers) will be deposited in NIH supported domain-specific data sharing repository (NIMH Data Archive). All data will be labeled with consistent unique identifiers that will make it easily findable in data repository to interested research investigators. Data will be available forever after sharing with data repository to other investigators for secondary analyses.
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Once the findings have been published or by the end of award performance period, whichever is sooner.
Any research investigator
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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Post-CABG patients with and without thiamine treatment.
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Participants will be assigned a random number, double-blind randomized, & longitudinal study design.
| Placebo | Drug | Participants will be given an infusion of the placebo treatment. |
|
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |