NCT02624024已完成不适用
AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,743
- 试验地点
- 8
- 主要终点
- Diagnosis of acute myocardial infarction (MI)
研究概览
简要总结
The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 21 years of age or older.
- •Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
- •Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).
排除标准
- •Subject is pregnant or may be pregnant.
- •Subject has an invalid written informed consent or has withdrawn consent.
结局指标
主要结局
Diagnosis of acute myocardial infarction (MI)
时间窗: during the first 24 hours after presentation to the emergency department
Diagnosis of acute myocardial infarction (MI) that a subject was experiencing at the time of the subject's presentation to the ED, as determined by independent adjudication panel and based on the Third Universal Definition of Myocardial Infarction.
次要结局
未报告次要终点
研究者
研究点 (8)
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