Coronary Heart DiseaseEarly Phase 1B1&CABGNCT06326996
Thiamine Intervention and Coronary Artery Bypass Grafting
A Early Phase 1 study testing Thiamine in people with Coronary Heart Disease and Coronary Artery Bypass Grafting, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Coronary Heart Disease, Coronary Artery Bypass Grafting
- What is being tested?
- Thiamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to 30 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
Rajesh Kumar, PHD, 310-825-1808, rkumar@mednet.ucla.edu
Nimangie Weerakoon, BA, 818-271-1096, nweerakoon@mednet.ucla.edu
About this study
Official title: Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical 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.
Read the 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.
- Being tested
- Thiamine, Placebo
- Keywords
- thiamine intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDrug
Also called Vitamin B1
Participants will be given an infusion of thiamine.
PlaceboDrug
Also called inactive
Participants will be given an infusion of the placebo treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Thiamine |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after CABG.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 months after CABG.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start10 Oct 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (128)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Post-CABG patients with and without thiamine treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rajesh Kumar, PhD, University of California, Los Angeles
- Investigators
- Rajesh Kumar, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326996
- Sponsor's protocol ID
- 23-001185
- Other IDs
- R21AG081720-01A1
- Acronym
- B1&CABG
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23479538Hodes 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.
PubMed 23479536Sheslow DA, W. . Wide range assessment of memory and learning (2nd edition) administration and technical manual In: Editor, ed.^eds. Wide range assessment of memory and learning (2nd edition) administration and technical manual. City: Psychological Assessment Resources, 2003.
Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
PubMed 23479546Ware J, Kosinski M, Dewey JE. How to score version 2 of the SF- 36 health survey. Lincoln, RI: QualityMetric Incorporated; 2000 p 229: 2000.
Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
PubMed 8437031Bolszak S, Casartelli NC, Impellizzeri FM, Maffiuletti NA. Validity and reproducibility of the Physical Activity Scale for the Elderly (PASE) questionnaire for the measurement of the physical activity level in patients after total knee arthroplasty. BMC Musculoskelet Disord. 2014 Feb 20;15:46. doi: 10.1186/1471-2474-15-46.
PubMed 24555852Paffenbarger RS Jr, Wing AL, Hyde RT. Physical activity as an index of heart attack risk in college alumni. Am J Epidemiol. 1978 Sep;108(3):161-75. doi: 10.1093/oxfordjournals.aje.a112608.
PubMed 707484Hall MJ, DeFrances CJ, Williams SN, Golosinskiy A, Schwartzman A. National Hospital Discharge Survey: 2007 summary. Natl Health Stat Report. 2010 Oct 26;(29):1-20, 24.
PubMed 21086860Frost L, Molgaard H, Christiansen EH, Hjortholm K, Paulsen PK, Thomsen PE. Atrial fibrillation and flutter after coronary artery bypass surgery: epidemiology, risk factors and preventive trials. Int J Cardiol. 1992 Sep;36(3):253-61. doi: 10.1016/0167-5273(92)90293-c.
PubMed 1358829Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
PubMed 22762316Silber JH, Rosenbaum PR, Schwartz JS, Ross RN, Williams SV. Evaluation of the complication rate as a measure of quality of care in coronary artery bypass graft surgery. JAMA. 1995 Jul 26;274(4):317-23.
PubMed 7609261Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
PubMed 11172175Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X.
PubMed 10334272Evered LA, Silbert BS, Scott DA, Maruff P, Ames D. Prevalence of Dementia 7.5 Years after Coronary Artery Bypass Graft Surgery. Anesthesiology. 2016 Jul;125(1):62-71. doi: 10.1097/ALN.0000000000001143.
PubMed 27127919
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiamine Intervention and Cognition in Older Adults Undergoing Coronary Artery Bypass Grafting - A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06326996
- Acronym / sponsor ID
- B1&CABG / 23-001185
- Keywords
- thiamine intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Post-CABG patients with and without thiamine treatment.
| Arm | Type | Receives |
|---|---|---|
| Post-CABG patients with Thiamine Treatment Intervention. | Experimental | Drug: ThiamineAssess 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 | Drug: PlaceboAssess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving placebo treatment within 5 days (baseline) and one month after CABG. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineAlso: Vitamin B1Participants will be given an infusion of thiamine. | Drug | Post-CABG patients with Thiamine Treatment Intervention. |
| PlaceboAlso: inactiveParticipants will be given an infusion of the placebo treatment. | Drug | Post-CABG patients without Thiamine Treatment Intervention. |
Primary outcome
Effects of thiamine treatment intervention on blood lactate levels.
Time frame: 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).
Effects of thiamine treatment intervention on blood thiamine levels.
Time frame: 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).
Effects of thiamine treatment intervention on blood inflammatory levels.
Time frame: 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.
Evaluate cognitive function in CABG patients with thiamine treatment.
Time frame: 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.
Time frame: 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.
Examine cognition in CABG patients with thiamine treatment.
Time frame: 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.
Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.
Time frame: 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.
Cognition assessment in CABG patients after thiamine treatment.
Time frame: 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.
Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.
Time frame: 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.
Long term effect of thiamine treatment intervention on quality of life.
Time frame: 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.
Long term effect of thiamine treatment intervention on daily activities using PASE.
Time frame: 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.
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 23479538Gershon 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.
- Background: PubMed 23479536Hodes 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.
- BackgroundSheslow DA, W. . Wide range assessment of memory and learning (2nd edition) administration and technical manual In: Editor, ed.^eds. Wide range assessment of memory and learning (2nd edition) administration and technical manual. City: Psychological Assessment Resources, 2003.
- Background: PubMed 23479546Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.
- BackgroundWare J, Kosinski M, Dewey JE. How to score version 2 of the SF- 36 health survey. Lincoln, RI: QualityMetric Incorporated; 2000 p 229: 2000.
- Background: PubMed 8437031Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
- Background: PubMed 24555852Bolszak S, Casartelli NC, Impellizzeri FM, Maffiuletti NA. Validity and reproducibility of the Physical Activity Scale for the Elderly (PASE) questionnaire for the measurement of the physical activity level in patients after total knee arthroplasty. BMC Musculoskelet Disord. 2014 Feb 20;15:46. doi: 10.1186/1471-2474-15-46.
- Background: PubMed 707484Paffenbarger RS Jr, Wing AL, Hyde RT. Physical activity as an index of heart attack risk in college alumni. Am J Epidemiol. 1978 Sep;108(3):161-75. doi: 10.1093/oxfordjournals.aje.a112608.
- Background: PubMed 21086860Hall MJ, DeFrances CJ, Williams SN, Golosinskiy A, Schwartzman A. National Hospital Discharge Survey: 2007 summary. Natl Health Stat Report. 2010 Oct 26;(29):1-20, 24.
- Background: PubMed 1358829Frost L, Molgaard H, Christiansen EH, Hjortholm K, Paulsen PK, Thomsen PE. Atrial fibrillation and flutter after coronary artery bypass surgery: epidemiology, risk factors and preventive trials. Int J Cardiol. 1992 Sep;36(3):253-61. doi: 10.1016/0167-5273(92)90293-c.
- Background: PubMed 22762316Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
- Background: PubMed 7609261Silber JH, Rosenbaum PR, Schwartz JS, Ross RN, Williams SV. Evaluation of the complication rate as a measure of quality of care in coronary artery bypass graft surgery. JAMA. 1995 Jul 26;274(4):317-23.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Kumar, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thiamine in people with Coronary Heart Disease and Coronary Artery Bypass Grafting, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Kumar, PhD (310-206-1699, rkumar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of thiamine treatment intervention on blood lactate levels. (time frame: Baseline and after 1 month after CABG.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326996, which also lists 128 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.