Evaluation of High Sensitivity Troponin I (hsTnI) in the Management of Patients With Chest Pain in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- First cardiovascular event
研究概览
简要总结
Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to 6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and gender. A health economics and outcome model will be applied using the optimal high sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI.
A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus high sensitivity troponin T (hsTnT) for all patients who present to the emergency department and require a blood draw. The outcomes of these patients will be tracked over the study period.
The purpose of conducting this study evaluation is:
- To shorten the chest pain protocol for suitable patients to < 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays.
- To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI+3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room (ER) with isolated suspected ACS.
- To establish the local reference norms for hsTnI assays.
详细描述
Purpose
Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to 6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and gender. A health economics and outcome model will be applied using the optimal high sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI.
A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus high sensitivity troponin T (hsTnT) for all patients who present to the emergency department and require a blood draw. The outcomes of these patients will be tracked over the study period.
The purpose of conducting this study evaluation is:
- To shorten the chest pain protocol for suitable patients to < 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays.
- To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI+3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room (ER) with isolated suspected ACS.
- To establish the local reference norms for hsTnI assays.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years and above
- •Ability to provide written, informed consent
- •Presentation to ER with chief complaint of chest pain OR has symptoms suggestive of angina equivalent without chest pain
- •ER physician determines patient has symptoms suggestive of ACS
- •ER physician orders troponin test for clinical purposes
排除标准
- •Diagnosed with STEMI
- •Poor pre-morbid Eg. Bedridden
- •Advanced malignancy/ terminal disease
结局指标
主要结局
First cardiovascular event
时间窗: 1 year
次要结局
未报告次要终点