跳至主要内容
临床试验/NCT03111862
NCT03111862已完成不适用

Observational Study on the Safety of Accelerated Rule-out Protocols in Patients Admitted With Chest Pain to a Crowded CPU

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 3,567 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,567
试验地点
1
主要终点
All-cause death

研究概览

简要总结

The aim of this observational study registry is to assess the safety of a Non-ST-elevation myocardial infarction (STEMI) rapid rule-out strategy as proposed by European Guidelines in patients presenting with suspected acute coronary syndrome to the emergency department.

详细描述

Design: mono-center observational study in a University chest pain unit

Duration: 12 months recruitment period starting June 2016 with end of recruitment July 2017. In the first 6 months assessment of situation, January 2017 introduction of fast protocols, i.e. 0/1 h as standard, observation of trend changes, utilization rates, safety from January 1st until July 2017. Another 90 days follow-up after last patient in.

Background: Several rule-out protocols recommended by 2015 European Society of Cardiology (ESC) guidelines, evidence supported by prospectively validated studies. However, no real life experience with ultilization rates and safety.

Particularly overcrowded emergency departments (EDs) or CPUs are likely to benefit most from fast rule-out protocols in order to discharge a substantial proportion of low risk patients.

Study group: consecutive patients presenting to CPU with suspected acute coronary syndrome (ACS) based on chest pain or chest pain equivalent symptoms

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

  • eligible to consent
  • >18 years

排除标准

  • NSTEMI rule-in
  • hs-TnT in observational zone
  • chronic hemodialysis
  • no consent
  • atrial tachyarrhythmias with chest pain or equivalent

结局指标

主要结局

All-cause death

时间窗: 30 days and 3 months

Survival free of all-cause death

次要结局

  • Rehospitalization for Acute Coronary Syndrome(30 days and 3 months)
  • Acute Myocardial Infarction(30 days and 3 months)
  • Rehospitalization for nonelective percutaneous coronary intervention(30 days and 3 months)

研究者

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

Dr. Moritz Biener

Principal Investigator

University Hospital Heidelberg

研究点 (1)

Loading locations...

相似试验