COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
研究概览
简要总结
Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis 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: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.
Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial
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
- •Adult, defined as subject 18 years of age or older
- •Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
- •At least one 12-lead electrocardiogram
排除标准
- •Currently pregnant
- •Trauma related admission
- •Cardiac arrest
- •Decline to participate
- •Did not present through the ED
- •Transferred from an outside hospital
结局指标
主要结局
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
时间窗: on admission
Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction
次要结局
- All-cause mortality(Up to 180-days)
- Cardiac death(Up to 180-days)
- Unstable angina(Up to 180-days)
- Acute myocardial infarction(Up to 180-days)
- Revascularization(Up to 180-days)
- Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.(30-days)