PRospective Evaluation of the European Society of Cardiology 0/1-hour Algorithm's Safety and Efficacy for Triage of Patients With Suspected Myocardial Infarction (PRESC1SE-MI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64,374
- 试验地点
- 20
- 主要终点
- Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation
研究概览
简要总结
The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm.
Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm.
The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 aged 18 and above
- •Presentation with acute non-traumatic acute chest pain to the emergency department
- •Suspicion of acute myocardial infarction
排除标准
- •Terminal kidney failure requiring dialysis
- •Cardiac arrest
- •Cardiogenic shock
研究组 & 干预措施
0/1-hour algorithm
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.
干预措施: European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm (Diagnostic Test)
0/3-hour algorithm
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.
干预措施: European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm (Diagnostic Test)
结局指标
主要结局
Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation
时间窗: 30 days
Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients
Time from ED presentation to ED discharge or transfer
时间窗: 30 days
Length of stay in the ED measured in hours
次要结局
- Proportion of patients managed as outpatients(24 hours)
- All-cause mortality at 30 days in all patients(30 days)
- Treatment costs in the ED(365 days)
- Readmission for suspected AMI within 30 days after index presentation(30 days)
- Length of stay in the ED(30 days)
- Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation(365 days)
- Effectiveness of rule-out(30 days)
- New AMI (type1) at 30 days in all patients(30 days)
- New AMI (type 1) at 365 days in all patients(365 days)
- Effectiveness of rule-in(30 days)
- Satisfaction of patients with their evaluation in the ED(30 days)
- All-cause mortality at 365 days in all patients(365 days)
- Feasibility of the 0/1-hour algorithm(80 minutes)