Valutazione Clinica e Farmacoeconomica Delle Metodiche di Dosaggio Per la TROponina CARdiaca Per la Diagnosi di NSTEMI Nel Setting Della Pratica Clinica Della Medicina di Pronto Soccorso Nel Territorio Nazionale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,913
- 试验地点
- 1
- 主要终点
- Time to diagnosis in the emergency department
研究概览
简要总结
Myocardial infarction is one of the leading causes of death and disability worldwide. In addition to standard diagnostic methods, it has been shown that high-sensitivity cardiac troponin assays allow greater sensitivity in the diagnosis of myocardial infarction and assume a central role for both exclusion ("rule out") and confirmation ("rule in") of acute myocardial infarction , while allowing to reduce the time interval between ER admission and presumptive diagnosis.
Considering the relevance of this topic, we propose to conduct an observational study in real world clinical practice settings at Emergency Departments, aiming to evaluate clinical and economic aspects deriving from the use of the different quantitative assays of high-sensitivity cardiac troponin currently available in patients with suspected acute myocardial infarction and non-ST-elevation ECG (NSTEMI) on the admission, including time of diagnosis and number of laboratory and imaging tests performed.
详细描述
Observational, prospective, real-world clinical practice, multicentric study, conducted at 12 Emergency Departments in Italy.
Patients with suspected non-ST-elevation myocardial infarction (NSTEMI) who have undergone at least one high-sensitivity cardiac troponin test will be included.
Patients will be enrolled in the study after verification of selection criteria.
Enrollment is consecutive; each Center will suspend enrollment when it has reached the expected number of patients.
An electronic data collection form (eCRF) will be used to automatically generate an enrollment number to identify each patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with chest pain
- •Performing at least one cardiac troponin determination test
- •Written informed consent
排除标准
- •Refusal to provide informed consent
- •Elevation of the ST segment to the ECG
- •Pregnancy or breastfeeding
- •Any other clinical condition not judged by the investigator compatible with participation in the present study.
结局指标
主要结局
Time to diagnosis in the emergency department
时间窗: 1-3-6 hours
Time from admission at the emergency department and diagnosis or exclusion of NSTEMI
次要结局
- 30-day mortality(30 days following admission)
- Number of ruled-in and ruled-out patients(1-3-6 hours)
- Number of patients diagnosed with a Major Adverse Clinical Event(30 days after the first assessment)
- Number of tests performed(1-3-6 hours)
研究者
Marco Marchetti
Director of the National Health Technology Assessment Centre
Istituto Superiore di Sanità