Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,101
- 试验地点
- 23
- 主要终点
- Clinical Performance - Area Under the Curve
研究概览
简要总结
The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.
详细描述
The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction.
All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
- •an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
- •greater than 18 years of age.
- •not known to be pregnant.
- •agreement to the follow-up required by the study.
排除标准
- •prior participation in this study.
- •require dialysis for end stage renal disease.
- •history of a previous heart transplant.
- •coexisting disorder associated with limited life expectancy.
- •currently participating in another investigational device or drug study.
结局指标
主要结局
Clinical Performance - Area Under the Curve
时间窗: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Clinical Performance- Sensitivity
时间窗: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Clinical Performance- Specificity
时间窗: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Clinical Performance- Negative Predictive Value (NPV)
时间窗: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
Clinical Performance- Positive Predictive Value (PPV)
时间窗: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
次要结局
- Prognosis(30-day and 90-day follow-up)