Tokyo, Dec. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059947) titled 'Assessment of neuroinflammation and immune function aimed at predicting the onset of delirium and improving clinical outcomes in patients with cardiovascular disease' on Dec. 8.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

Condition: Condition - Patients scheduled for cardiovascular surgery Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to clarify how neuroinflammation and immune function influence the onset, clinical manifestations, and prognosis of delirium, a condition whose risk increases with aging. By elucidating these mechanisms, the study seeks to facilitate the development of new therapeutic strategies targeting brain inflammation and immune function. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Activated-astrocyte PET imaging ([18F]SMBT-1-PET)

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Individuals who have provided written informed consent for participation in the study. 2. Men and women aged 18 years or older at the time of consent. 3. Individuals scheduled to undergo cardiovascular surgery. 4. Individuals with no history of neurological disorders that could affect the study assessments. 5. Individuals who agree to the storage of biological samples in the NCVC Biobank. Key exclusion criteria - 1. Individuals judged by the principal investigator or study physicians to be at a higher-than-usual risk of health injury due to participation in this study. 2. Individuals deemed unable to undergo the study examinations. 3. Individuals with severe comorbidities, or a history of such conditions, for whom the principal investigator or study physicians consider participation inappropriate. 4. Individuals with a history of psychiatric disorders, such as dementia or depression. 5. Individuals who are unable to remain still during examinations (applicable only when PET imaging is performed). 6. Individuals with a history of drug allergy (applicable only when PET imaging is performed). 7. Pregnant or possibly pregnant women, and breastfeeding women (applicable only when PET imaging is performed). 8. Individuals taking reversible or irreversible monoamine oxidase (MAO) inhibitors (applicable only when PET imaging is performed). 9. Individuals who smoke (applicable only when PET imaging is performed). 10. Any other individuals deemed unsuitable for participation by the principal investigator or study physicians. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 02 Day Date of IRB - 2025 Year 10 Month 02 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068566

Disclaimer: Curated by HT Syndication.