Use of High Sensitivity Cardiac Troponin in Safely Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction (SAFETY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of acute myocardial infarction - Abbott hs-cTnI
研究概览
简要总结
Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
详细描述
Background: Studies addressing the clinical performance of the Siemens Healthineers High-Sensitivity Troponin I assay (TnIH) on the Atellica IM analyzer for the diagnosis and rule out of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.
Study objective: Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Hypothesis
The Atellica IM TnIH assay will offer an excellent diagnostic performance for acute myocardial injury and acute myocardial infarction, as well as expedite the risk stratification of patients for early discharge from the emergency department.
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
- •Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
- •At least one 12-lead electrocardiogram
排除标准
- •Less than 18 years old
- •Decline to participate
- •Did not present through the ED
- •Transferred from an outside hospital or clinic.
结局指标
主要结局
Incidence of acute myocardial infarction - Abbott hs-cTnI
时间窗: Day 1
Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay
Incidence of myocardial infarction - Roche Gen 5 cTnT
时间窗: Day 1
Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay
Incidence of myocardial infarction - Abbott contemporary cTnI
时间窗: Day 1
Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay
次要结局
- Number of participants that underwent revascularization(up to 180 days)
- All-cause mortality(up to 180 days)
- Adjudicated index acute myocardial infarction according to 4th UDMI(on admission)
- Cardiac mortality(up to 180 days)
- Safety Outcome - MACE(180 days)