NCT07217431已完成不适用
Access BNP on DxI 9000 Clinical Performance Evaluation: Specimen Testing and Clinical Concordance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,361
- 试验地点
- 3
- 主要终点
- Heart failure positive subjects
研究概览
简要总结
The goal is to establish clinical performance of a BNP assay on the intended use population and establish clinical concordance on a separate device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •There is no direct inclusion criteria for this study, Samples were collected under a separate enrollment protocol
排除标准
- •Hemolysis observed per CLSIC56A grading scale
- •Icterus (bilirubin) observed 4+ per CLSIC56A grading scale
结局指标
主要结局
Heart failure positive subjects
时间窗: Through study completion, approximately 9 months
Subjects with BNP value above clinical decision point
次要结局
- Heart failure negative subjects(Through study completion, approximately 9 months)
研究者
研究点 (3)
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