Role of Pre-discharge vs. Early Post-discharge Stress Testing and Implementation of the GRACE Risk Score for Safe Discharge of Patients With an ACS and a Negative High Sensitivity Troponin T Result Within 3 Hours After Presentation to a Chest Pain Unit
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular event
研究概览
简要总结
New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score >140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.
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
- •patients presenting to the emergency department ("chest pain unit")
- •typical angina pectoris
- •absence of symptoms since presentation
- •at least 18 years
- •low GRACE risk score (<140 points)
- •informed consent, signed agreement
排除标准
- •conditions with need for immediate workup
- •mental disorders
- •pregnancy, breast feeding
结局指标
主要结局
Major adverse cardiovascular event
时间窗: 30 days
次要结局
- Major adverse cardiovascular event(90 days)
研究者
Professor Hugo Katus
Head of Cardiology
University Hospital Heidelberg
