NIPH Clinical Trials Search

Development and Multicenter Validation of a Near-Infrared Spectroscopy System for Acute Stroke Diagnosis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	patients suspected of stroke
Date of first enrollment	08/12/2025
Target sample size	500
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

Monitoring and analysis of changes in Delta cHb, Delta O2Hb, and Delta HHb, as well as PlsO2 and TOI data, including absolute values and inter-hemispheric differences.

Secondary Outcome

To assess the diagnostic capability of various stroke scales, calculated from information obtained via the standardized Ibaraki Prefecture prehospital and emergency observation records, in classifying stroke subtypes. Furthermore, we will compare these findings with perfusion imaging software evaluations to investigate the relationship between cerebral blood flow changes and changes in hemoglobin concentrations. Finally, we will investigate the association between changes in hemoglobin concentrations and various clinical data suspected of influencing cerebral blood flow.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Age 18 years old. Cases transported by emergency services utilizing the Ibaraki Prefecture Emergency Observation Criteria. All patients suspected of stroke by emergency medical services personnel or by the initial treating physician.
Exclude criteria	Patients who are pregnant. Patients requiring isolation due to suspected infectious disease.