Tiamiiniinterventio ja sepelvaltimon ohitussiirto (B1&CABG)
torstai 5. marraskuuta 2026 päivittänyt: Rajesh Kumar, PhD, University of California, Los Angeles
Tiamiiniinterventio ja kognitio vanhemmilla aikuisilla, joille tehdään sepelvaltimon ohitusleikkaus – satunnaistettu kliininen tutkimus.
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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
52
Vaihe
- Varhainen vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Rajesh Kumar, PhD
- Puhelinnumero: 310-206-1699
- Sähköposti: rkumar@mednet.ucla.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Nimangie Weerakoon, BA
- Puhelinnumero: 818-271-1096
- Sähköposti: nweerakoon@mednet.ucla.edu
Opiskelupaikat
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California
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Los Angeles, California, Yhdysvallat, 90095
- Rekrytointi
- UCLA
-
Ottaa yhteyttä:
- Rajesh Kumar, PHD
- Puhelinnumero: 310-825-1808
- Sähköposti: rkumar@mednet.ucla.edu
-
Päätutkija:
- Rajesh Kumar, PHD
-
Ottaa yhteyttä:
- Nimangie Weerakoon, BA
- Puhelinnumero: 818-271-1096
- Sähköposti: nweerakoon@mednet.ucla.edu
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
60 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
|
|
Placebo Comparator: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Effects of thiamine treatment intervention on blood lactate levels.
Aikaikkuna: 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.
|
|
Effects of thiamine treatment intervention on blood thiamine levels.
Aikaikkuna: 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.
|
|
Effects of thiamine treatment intervention on blood inflammatory levels.
Aikaikkuna: 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.
|
|
Evaluate cognitive function in CABG patients with thiamine treatment.
Aikaikkuna: 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.
|
|
Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment.
Aikaikkuna: 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.
|
|
Examine cognition in CABG patients with thiamine treatment.
Aikaikkuna: 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.
|
|
Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment.
Aikaikkuna: 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.
Aikaikkuna: 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.
|
|
Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment.
Aikaikkuna: 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.
|
|
Long term effect of thiamine treatment intervention on quality of life.
Aikaikkuna: 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.
|
|
Long term effect of thiamine treatment intervention on daily activities using PASE.
Aikaikkuna: 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.
|
|
Long term effect of thiamine treatment intervention on daily activities using PPA.
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: Rajesh Kumar, PhD, University of California, Los Angeles
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 23-001185
- R21AG081720-01A1 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
Once the findings have been published or by the end of award performance period, whichever is sooner.
IPD-jaon käyttöoikeuskriteerit
Any research investigator
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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