Tiaminintervention och kranskärlsbypasstransplantation (B1&CABG)
5 november 2026 uppdaterad av: Rajesh Kumar, PhD, University of California, Los Angeles
Tiaminintervention och kognition hos äldre vuxna som genomgår kranskärlsbypasstransplantation - en randomiserad klinisk prövning.
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
52
Fas
- Tidig fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Rajesh Kumar, PhD
- Telefonnummer: 310-206-1699
- E-post: rkumar@mednet.ucla.edu
Studera Kontakt Backup
- Namn: Nimangie Weerakoon, BA
- Telefonnummer: 818-271-1096
- E-post: nweerakoon@mednet.ucla.edu
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90095
- Rekrytering
- UCLA
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Kontakt:
- Rajesh Kumar, PHD
- Telefonnummer: 310-825-1808
- E-post: rkumar@mednet.ucla.edu
-
Huvudutredare:
- Rajesh Kumar, PHD
-
Kontakt:
- Nimangie Weerakoon, BA
- Telefonnummer: 818-271-1096
- E-post: nweerakoon@mednet.ucla.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
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Placebo-jämförare: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Effects of thiamine treatment intervention on blood lactate levels.
Tidsram: 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). |
Baseline and after 1 month after CABG.
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Effects of thiamine treatment intervention on blood thiamine levels.
Tidsram: 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). |
Baseline and after 1 month after CABG.
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Effects of thiamine treatment intervention on blood inflammatory levels.
Tidsram: 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. |
Baseline and after 1 month after CABG.
|
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Evaluate cognitive function in CABG patients with thiamine treatment.
Tidsram: 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. |
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.
Tidsram: 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. |
6 months after CABG.
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Examine cognition in CABG patients with thiamine treatment.
Tidsram: 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. |
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.
Tidsram: 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. |
6 months after CABG.
|
|
Cognition assessment in CABG patients after thiamine treatment.
Tidsram: 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. |
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.
Tidsram: 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. |
6 months after CABG.
|
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Long term effect of thiamine treatment intervention on quality of life.
Tidsram: 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. |
6 months after CABG.
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Long term effect of thiamine treatment intervention on daily activities using PASE.
Tidsram: 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. |
6 months after CABG.
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Long term effect of thiamine treatment intervention on daily activities using PPA.
Tidsram: 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). |
6 months after CABG.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Rajesh Kumar, PhD, University of California, Los Angeles
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 oktober 2024
Primärt slutförande (Beräknad)
30 september 2027
Avslutad studie (Beräknad)
30 september 2027
Studieregistreringsdatum
Först inskickad
7 mars 2024
Först inskickad som uppfyllde QC-kriterierna
20 mars 2024
Första postat (Faktisk)
25 mars 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 november 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 23-001185
- R21AG081720-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Once the findings have been published or by the end of award performance period, whichever is sooner.
Kriterier för IPD Sharing Access
Any research investigator
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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