Comparison of Troponin Assay With New POCT Method and in the Automation in the Decision-making Pathway of Patient With Chest Pain Suspected of Acute Myocardial Ischemia Entering the Emergency Room (POCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system
研究概览
简要总结
This is a prospective observational study aiming to evaluate the diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system (by comparison with the results obtained with the Atellica diagnostic system currently in use) and to evaluate the impact of the POCT system on the reduction of decision-making time (particularly of "rule-out"), by evaluating the number of cases in which the conclusion of the decision pathway at 3 h (algorithm currently in use) could have been concluded at 1 h.
详细描述
Patients accessing the emergency room for chest pain suspected of acute myocardial ischemia, who are asked for Troponin determination for the decision pathway, will be asked to participate at the study. A blood draw will be performed (for determination of Troponin value, with classical method in use and with POCT method) at time:
- Zero (acess at the emergency room)
- 1 h
- 3 h
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency department access for acute non-traumatic chest pain suspected of myocardial ischemia
- •Sign of Informed Consent
排除标准
- •Diagnostic electrocardiographic picture for Acute Coronary Syndrome-STEMI (ACS-STEMI)
- •Absence of symptomatology in the 12 hours prior to admission to the emergency room
- •Post-traumatic chest pain
结局指标
主要结局
The diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system
时间窗: through study completion, an average of 1 year
Evaluate the diagnostic accuracy of the high-sensitivity Troponin assay performed with the Atellica VTLi POCT system by comparison with results obtained with the Atellica diagnostic system currently in use
次要结局
- The impact of the POCT system on the reduction of decision-making time(through study completion, an average of 1 year)