Performance testing aimed at obtaining pharmaceutical approval for rapid diagnostic reagents for home medical care

JRCT ID: jRCT1031240595

Registered date:07/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Inflammatory diseases, myocardial infarction, thrombosis
• Date of first enrollment: 07/01/2025
• Target sample size: 60
• Study type: Interventional
• Intervention(s): A small amount of blood is drawn from patients and healthy individuals.

Outcome(s)

• Primary Outcome: The remaining samples will be used to examine the correlation between the measurements taken during clinical testing and those taken using the test drug being developed by UMA, and to evaluate the performance of the test drug.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: For the four test items of CRP, high-sensitivity CRP (inflammation), CKMB (myocardial infarction), and D-dimer (thrombosis), concentrations will be measured using a rapid test drug currently being developed by UMA using residual samples that have already been tested in the testing department, and the data will be compared with existing reagents.
• Exclude criteria: Those who indicated their refusal to participate in the study through a disclosure document.

Related Information

• Primary Sponsor: Matsushita Kazuyuki
• Secondary Sponsor: UMA Co., Ltd.