Intervenção com tiamina e cirurgia de revascularização do miocárdio (B1&CABG)
5 de novembro de 2026 atualizado por: Rajesh Kumar, PhD, University of California, Los Angeles
Intervenção e cognição com tiamina em idosos submetidos à cirurgia de revascularização do miocárdio - um ensaio clínico randomizado.
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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
52
Estágio
- Fase inicial 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Rajesh Kumar, PhD
- Número de telefone: 310-206-1699
- E-mail: rkumar@mednet.ucla.edu
Estude backup de contato
- Nome: Nimangie Weerakoon, BA
- Número de telefone: 818-271-1096
- E-mail: nweerakoon@mednet.ucla.edu
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90095
- Recrutamento
- UCLA
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Contato:
- Rajesh Kumar, PHD
- Número de telefone: 310-825-1808
- E-mail: rkumar@mednet.ucla.edu
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Investigador principal:
- Rajesh Kumar, PHD
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Contato:
- Nimangie Weerakoon, BA
- Número de telefone: 818-271-1096
- E-mail: nweerakoon@mednet.ucla.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
60 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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. |
Participants will be given an infusion of thiamine.
Outros nomes:
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Comparador de Placebo: 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. |
Participants will be given an infusion of the placebo treatment.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Effects of thiamine treatment intervention on blood lactate levels.
Prazo: Baseline and after 1 month after CABG.
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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.
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Effects of thiamine treatment intervention on blood thiamine levels.
Prazo: Baseline and after 1 month after CABG.
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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.
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Effects of thiamine treatment intervention on blood inflammatory levels.
Prazo: Baseline and after 1 month after CABG.
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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.
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Evaluate cognitive function in CABG patients with thiamine treatment.
Prazo: Baseline and after 1 month after CABG.
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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.
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Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.
Prazo: 6 months after CABG.
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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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Examine cognition in CABG patients with thiamine treatment.
Prazo: Baseline and 1 month after CABG.
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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.
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Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.
Prazo: 6 months after CABG.
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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.
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Cognition assessment in CABG patients after thiamine treatment.
Prazo: Baseline and 1 month after CABG.
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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.
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Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.
Prazo: 6 months after CABG.
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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.
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Long term effect of thiamine treatment intervention on quality of life.
Prazo: 6 months after CABG.
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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.
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Long term effect of thiamine treatment intervention on daily activities using PASE.
Prazo: 6 months after CABG.
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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.
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Long term effect of thiamine treatment intervention on daily activities using PPA.
Prazo: 6 months after CABG.
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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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rajesh Kumar, PhD, University of California, Los Angeles
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de outubro de 2024
Conclusão Primária (Estimado)
30 de setembro de 2027
Conclusão do estudo (Estimado)
30 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
7 de março de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de março de 2024
Primeira postagem (Real)
25 de março de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de novembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de novembro de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23-001185
- R21AG081720-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
Once the findings have been published or by the end of award performance period, whichever is sooner.
Critérios de acesso de compartilhamento IPD
Any research investigator
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .