Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of CEB in detecting myocardial injury
研究概览
简要总结
This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker) in patients who are undergoing cardiac investigations.
详细描述
This project is aiming to identify the diagnostic utility of an ECG derived measurement by a Medical device (Vectraplex by VectraCor ltd) in patients who are undergoing cardiac investigations. This technology is based on the principle of vector ECG and an analysing system that computes a composite score termed a Cardiac Electrical Biomarker (CEB TM).
CEB has been validated in the detection of STEMI with high sensitivity and specificity in the detection ECG changes characteristic to STEMI. The CEB may be a more accurate way of identifying heart injury and causes of chest pain compared to standard tests, which could lead to faster diagnosis and treatment of these patients.
The diagnostic utility of the CEBTM in the following:
- Acute chest pain assessment in the A&E department.
- Acute chest pain assessment in the Primary Care Surgery.
- Performance of CEB during inducible ischaemia in patients with stable angina
- Performance of CEB during acute ischaemia in patients undergoing percutaneous coronary intervention (PCI)
- Performance of CEB in patients undergoing cardio-toxic treatment
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of CEB in detecting myocardial injury
时间窗: Day 1
Metrics: sensitivity, specificity, PPV, NPV
次要结局
- Correlation between CEB and non-fatal myocardial infarction(30 days and 12 months)
- Correlation between CEB and readmission with progressive angina(30 days and 12 months)
- Relationship between CEB and need for revascularisation(30 days and 12 months)
- Correlation between CEB and cardiovascular mortality(30 days and 12 months)
研究者
Joanne Turner
Academic Research Coordinator
Milton Keynes University Hospital NHS Foundation Trust