Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,496
- 试验地点
- 2
- 主要终点
- Length of stay in the Emergency Department (ED)
研究概览
简要总结
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
详细描述
Ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. Patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ED) and impose a high work-load on hospitals. Since 2009, high-sensitivity cardiac troponin (hs-cTn) assays have become a crucial ED tool for differentiating between patients with and without Non-ST-elevation myocardial infarction (NSTEMI). Accordingly, the European Society of Cardiology (ESC) recommends 0-1 hour algorithms that use hs-cTn for rule-out and rule-in of NSTEMI.
Additionally, the clinical suspicion of acute coronary syndrome (ACS) or other life-threating conditions must be low.
Unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins.
The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.
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 > 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS
排除标准
- •STEMI (ECG criteria)
- •Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling
- •Patients admitted from Nursing homes
- •Patients transferred from other hospitals (e.g. for PCI treatment)
- •Less than 2 months life expectancy from comorbid clinical conditions
- •Not possible to provide informed consent due to cognitive impairment, language problems or other reasons
结局指标
主要结局
Length of stay in the Emergency Department (ED)
时间窗: Up to 24 hours
Difference in length of stay in the ED will be compared between the two arms
次要结局
- Total patient episode costs(Up to 3 months)
- Total length of stay(Up to 3 months)
- Composite of myocardial infarction and death(1 year)
- Composite of myocardial infarction, death and revascularization(1 year)
- Symptom burden(30 days)
- Patients quality of life according to RAND-12(30 days)
- 12 months costs(12 months)
- Patient satisfaction(30 days)
- Discharge rate at 3 hours(3 hours)
- Discharge rate at 6 hours(6 hours)