跳至主要内容
临床试验/NCT02072538
NCT02072538撤回不适用

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

University Hospital Heidelberg1 个研究点 分布在 1 个国家开始时间: 2014年4月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Hugo Katus

Head of Cardiology

University Hospital Heidelberg

研究点 (1)

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