VITROS Immunodiagnostic Products hs Troponin I
试验速览
- 阶段
- 不适用
- 入组人数
- 1,630
- 试验地点
- 24
- 主要终点
- Sensitivity and specificity of the VITROS hs Troponin I test
研究概览
简要总结
The purpose of this clinical study is to collect data to substantiate the use of the VITROS hs Troponin I test as an aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.
详细描述
A prospective clinical sample collection and cardiac troponin I testing will be conducted in individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who meet the inclusion/exclusion criteria, including having signed an informed consent form will be included in the study.
Clinical and laboratory data will be collected to demonstrate product performance compared to an adjudicated clinical diagnosis.
Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be performed under two separate protocols.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ≥22 years of age at the time of consent.
- •Subject presenting with symptoms suggestive of acute coronary syndrome including chest pain, or chest pain equivalent.
- •Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of care.
- •Subject willing and able to provide informed consent.
排除标准
- •Subject is unable to comply with the study requirements.
- •Any samples which were not obtained under IRB approved protocol.
结局指标
主要结局
Sensitivity and specificity of the VITROS hs Troponin I test
时间窗: VITROS hs Troponin I value at > 6 hours and up to 9 hours
Evaluate the sensitivity and specificity of the VITROS hs Troponin I test result against the adjudicated diagnosis for subjects with acute coronary syndrome (ACS).
次要结局
- Rule in and rule out myocardial infarction (MI)(VITROS hs Troponin I values from two collection time points (baseline, > 1 hour and up to 2 hours))
- Risk stratification of subjects(Up to 12 months after last enrollment)