NCT02002546已完成不适用
Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in Troponin value over a two hour interval.
研究概览
简要总结
- In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I as measured by the i-STAT immunoassay reliably identifies and excludes an acute myocardial infarction.
- In chest pain patients with suspected acute coronary syndrome whose baseline troponin is above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by the i-STAT immunoassay accurately discriminates between acute myocardial infarction and non-acute myocardial infarction troponin elevations.
详细描述
Primary Aims: 1) Demonstrate that a 2hr delta troponin as measured by the i-STAT platform can reliably identify and exclude MI on the initial ED evaluation. 2)Demonstrate that a 2hr delta troponin is useful in the discrimination AMI versus non-AMI conditions in patients with low abnormal baseline Troponin-I values.
Secondary Aims: 1) Demonstrate that a positive 2-hr delta troponin-I identifies patients at highest risk for 30 day ACE. 2) Other Secondary aims TBD.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18 years of age or older
- •Chest pain suspicious for ACS
- •Absence of ST-segment elevation AMI (STEMI) or STEMI equivalent on the initial ECG
- •Baseline i-STAT troponin less or equal to 1.0 ng/ml
- •Enrollment initiated before 2 hour 'delt' troponin value available for review
- •Ability and willingness to participate and cooperate with telephone follow-up evaluations
排除标准
- •ST-elevation or other ECG criteria that results in the diagnosis of AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics
- •Patients with chest pain not deemed to warrant cardiac screening
- •Blunt chest trauma
- •Tachyarrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
- •Cardiac Arrest prior to arrival
- •Hemodynamically unstable patients
- •Pulmonary edema requiring CPAP, BIPAP, or mechanical ventilation
- •Baseline i-STAT troponin measurement greater than 1.0 ng/ml
- •Baseline and 2-hour i-STAT Troponin measurements not obtained
- •Patient (or Legal Representative) unable or unwilling to provide written informed consent
- •Subject unwilling or unlikely to comply with study procedures, including protocol-specific blood sampling
- •Subject unwilling, unable, or deemed unlikely to respond or participate in telephone follow-up
- •Vulnerable populations as deemed inappropriate for the study
结局指标
主要结局
Change in Troponin value over a two hour interval.
时间窗: 2 hours after baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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