Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 14
- 主要终点
- Clinical performance of the Meritas Troponin I test
研究概览
简要总结
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)
详细描述
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel.
After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.
研究设计
- 研究类型
- Observational
- 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
- •The informed consent must be signed by the subject, or the subject's legal authorized representative.
- •21 years of age or greater at the time of enrollment
- •Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial ischemia, such as but not limited to: subjects currently having chest pain, pressure or a burning sensation across the precordium and epigastrium, pain that radiates to neck, shoulder, jaw, back, upper abdomen and either arm.
排除标准
- •Informed consent form not signed
- •Age <21 years
- •Known pregnancy -
结局指标
主要结局
Clinical performance of the Meritas Troponin I test
时间窗: 24-hours
Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI)
次要结局
- Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).(1 year)