Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 404
- 试验地点
- 10
- 主要终点
- Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia
研究概览
简要总结
The objective of the study is to assess the performance characteristics of Apo J-Glyc as a novel biomarker for the early detection of myocardial ischaemia in patients with suspected acute coronary syndromes.
详细描述
This in vitro diagnosis clinical validation will test the Performance Characteristics of Apo J-Glyc measured with a novel in vitro diagnostic (IVD) test. Blood samples from eligible consenting subjects will be collected at hospital admission, throughout different post admission times (1h, 3h, 24h and 72h or discharge). The quantification of circulating Apo J-Glyc levels will be analysed in correlation with clinical data providing information about Apo J-Glyc as an ischaemia biomarker and its diagnostic and 6-months prognostic value.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal or above 18 years old
- •Chest pain of suspected cardiac origin
- •Signature of informed consent
- •Able and willing to comply with study requirements
排除标准
- •Prior inclusion in the same study
- •Life expectancy less than 6 months
- •Previous inclusion in a therapy-related clinical trial (except clinical trials testing Medical Devices such as stents and/or balloons)
结局指标
主要结局
Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia
时间窗: 3 hours
Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia as compared to final diagnosis at discharge following routine practice to manage chest pain patients with possible ACS.
Specificity
时间窗: 3 hours
Specificity results will be generated from subject's blood collected at different collection time points.
Area under the Receiver Operating characteristic Curve (A-ROC curve)
时间窗: 3 hours
Area under the Receiver Operating characteristic Curve will be used to determine the optimum clinical sensitivity and specificity. Results will be generated from subject's blood collected at different collection time points.
Sensitivity
时间窗: 3 hours
Sensitivity results will be generated from subject's blood collected at different collection time points.
Positive Predictive Value (PPV)
时间窗: 3 hours
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Negative Predictive Value (NPV)
时间窗: 3 hour
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
次要结局
- Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE).(From admission to up to 6 months)