VITROS Immunodiagnostic Products NT-proBNP II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,246
- 试验地点
- 25
- 主要终点
- Sensitivity and Specificity of the VITROS NT-proBNP II assay
研究概览
简要总结
Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart failure (HF). The purpose of this clinical study is to collect data to substantiate the use of the VITROS NT-proBNP II assay.
详细描述
A prospective clinical sample collection and NT-proBNP testing will be conducted in two populations. Patients presenting to the Emergency Department (ED) and patients presenting to outpatient centers will be approached for enrollment.
Clinical and laboratory data will be collected to demonstrate product performance compared to adjudicated clinical diagnosis. Approximately 4300 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.
Sample collection and testing of clinical samples with the VITROS NT-proBNP II assay will be performed under two separate protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects must have suspicion of HF and acute symptoms at presentation.
- •Subjects must be at least 22 years of age.
- •Subjects must be willing and able to provide informed consent.
排除标准
- •Acute symptoms clearly not secondary to HF.
- •Subjects with renal disease on dialysis.
- •Subjects unable to comply with the study requirements.
- •Population with suspicion of HF (Outpatient Setting):
- •Inclusion Criteria:
- •Subjects must be at least 22 years of age.
- •Subjects must be willing and able to provide informed consent.
- •Subjects who present to outpatient centers with suspicion HF.
- •Exclusion Criteria:
- •Symptoms clearly not secondary to HF.
- •Subjects with renal disease on dialysis.
- •Subjects unable to comply with the study requirements.
- •Subjects previously diagnosed with heart failure.
结局指标
主要结局
Sensitivity and Specificity of the VITROS NT-proBNP II assay
时间窗: Single blood draw upon study entry 1day
Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis.
次要结局
- Heart Failure Severity Assessment(Single blood draw upon study entry 1 day)