Evaluation of the Siemens POC HS CTn-I Test System
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
- Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction
研究概览
简要总结
The Siemens POC High Sensitivity Troponin-I Test System is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTn-I) in fresh human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory.
The Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).
详细描述
Study purpose/objective:
- Evaluate the clinical performance of the Siemens POC HS cTn-I test system for the diagnosis and rule out of AMI in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
- Correlate the blood and plasma outcomes on the Siemens POC HS cTn-I test system as function of the corresponding hematocrit (Hct) values.
Hypothesis
The Siemens POC HS cTn-I Test System 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS event.
- •Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
- •At least one 12-lead electrocardiogram
- •Exclusion Criteria
- •Less than 21 years old
- •Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
- •Did not present through the ED
- •Transferred from an outside hospital or clinic.
排除标准
- 未提供
结局指标
主要结局
Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction
时间窗: Day 1
Examine the diagnostic performance for a) acute myocardial injury and b) acute myocardial infarction based on various diagnostic strategies using hs-cTnI measurement(s), as follows: 1. Single measurement strategies 1. Limit of detection (LoD) 2. Concentration threshold tailored to meet a clinical need: Derive an optimal rule-out ng/L cutoff for Siemens POC HS cTn-I Test System. 2. Accelerated serial sampling (0/2h protocol) 1. Using the both sex-specific and overall 99th percentiles 2. Delta (absolute concentration serial change value, 0-2h) analysis
Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs
时间窗: Day 1
Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs, including patients categorized with acute myocardial injury and acute myocardial infarction, including type 1 and 2 myocardial infarction following the 4th Universal Definition of Myocardial Infarction.
Impact on the incidence of myocardial injury and myocardial infarction diagnoses.
时间窗: Day 1
Examine the potential impact on the incidence of myocardial injury and myocardial infarction diagnoses using hs-cTnI upon clinical practice implementation with a comparison to the hospital's final ICD-10 code diagnosis of type 1 and type 2 MIs.
Examine Concordance
时间窗: Day 1
Examine concordance (dis) between hs-cTnI in comparison to a high sensitivity (Abbott \& Siemens Healthineers) cTnI assay
Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Siemens POC HS cTn-I Test System
时间窗: Day 1
Examine the incidence of undetectable(\<LoD), measurable (LoD - 99th percentile), and increased (\>99th percentile) cTn concentrations for the Siemens POC HS cTn-I Test System in comparison to a high sensitivity cTnI assay (Abbott \& Siemens Healthineers) to determine the potential impact on positivity rate, defined by sex-specific 99th percentiles.
次要结局
- Adjudicated index acute myocardial infarction according to 4th UDMI(on admission)
- Safety Outcome - MACE(30 days)
- All-cause mortality(up to 30 days)
- Cardiac mortality(up to 30 days)