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Assessment of neuroinflammation and immune function aimed at predicting the onset of delirium and improving clinical outcomes in patients with cardiovascular disease.

Assessment of neuroinflammation and immune function aimed at predicting the onset of delirium and improving clinical outcomes in patients with cardiovascular disease. - AIM-BRAIN study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059947
Enrollment
30
Registered
2025-12-08
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for cardiovascular surgery

Interventions

Activated-astrocyte PET imaging ([18F]SMBT-1-PET)

Sponsors

National Center for Geriatrics and Gerontology
Lead Sponsor
National Cerebral and Cardiovascular Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To evaluate the severity of delirium in patients scheduled for cardiovascular surgery and to clarify its association with blood biomarkers reflecting neuroinflammation and immune function.

Secondary

MeasureTime frame
To elucidate the relationship between activated-astrocyte PET imaging and blood biomarkers reflecting neuroinflammation and immune function. To elucidate the association between regional astrocyte activation and the onset and severity of delirium.

Countries

Japan

Contacts

Public ContactYasuyuki Kimura

National Center for Geriatrics and Gerontology Department of Clinical and Experimental Neuroimaging

yazkim@ncgg.go.jp0562-46-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026