Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulf Ekelund
- 入组人数
- 16,000
- 试验地点
- 4
- 主要终点
- AMI and all-cause death
研究概览
简要总结
Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these patients undergo lengthy assessments in the ED or are admitted which contributes to ED and hospital crowding as well as a substantial health care burden. The now commonly used high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been observational. The safety and effectiveness of the protocol when implemented in routine care is thus unknown.
The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.
详细描述
STUDY DESIGN:
ESC-TROP is a before-and-after implementation study with concurrent controls that will evaluate the safety and effectiveness of a 0h/1h hs-cTnT protocol. The intervention group will consist of ED chest pain patients enrolled during 10 months after implementation of this protocol in routine care at the three intervention sites, and the control groups will be chest pain patients managed at the same EDs during the corresponding 10 months of the previous year, as well as chest pain patients managed during the same before-and-after period at two EDs not implementing the protocol (concurrent controls).
OBJECTIVES:
To determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.
ELIGIBILITY CRITERIA:
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
- •ED presentation with a primary complaint of non-traumatic chest pain
- •Age ≥18 years
排除标准
- •A final diagnosis of STEMI during the index visit
- •No hs-cTnT ordered
- •Patient leaving against medical advice
- •No Swedish personal identification number
- •Previous enrollment
- •Unwillingness to participate
结局指标
主要结局
AMI and all-cause death
时间窗: 30 days from ED presentation
Comparison of the rate of AMI and all-cause death within 30 days from ED presentation in patients discharged from the ED during the intervention period versus the control period (safety)
ED length of stay
时间窗: Through discharge from the ED, on average 5 hours after ED presentation
Comparison of ED length of stay in patients discharged from the ED during the intervention period versus the control period (effectiveness)
次要结局
- Proportion of ED patients discharged(Through discharge from the ED, on average 5 hours after ED presentation)
- Proportion of patients fulfilling 0h/1h hs-cTnT criteria who have undergone objective testing(30 days from ED presentation)
- Non-ACS coronary care unit admissions(Throughout index hospital visit, on average 2 days after ED presentation)
- Inappropriate coronary angiographies(Throughout index hospital visit, on average 2 days after ED presentation)
- Total hospital length of stay(Through discharge from the index hospital visit, on average 2 days after ED presentation)
- ED revisits(30 days from ED presentation)
- New admissions(30 days from ED presentation)
- Health care costs(30 days from ED presentation)
研究者
Ulf Ekelund
Principal Investigator, Professor of Emergency Medicine
Region Skane