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临床试验/NCT03494556
NCT03494556已完成不适用

Translating Evidence-Based Chest Pain Decision Aids to the Prehospital Environment

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2018年4月18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
365
试验地点
2
主要终点
Determine whether prehospital chest pain decision aid use is feasible.

研究概览

简要总结

Decision aids such as the HEART Pathway, Emergency Department Assessment of Chest Pain Score (EDACS), Revised Geneva Score and PERC Score have similar ability to accurately risk stratify Emergency Department (ED) patients with possible Acute Coronary Syndrome (ACS) and Pulmonary Embolism (PE) and have become standard practice in the ED setting. This study seeks to determine whether prehospital use of these decision aids is feasible and determine which are the most sensitive and specific for prediction of ACS and PE, respectively.

详细描述

To accomplish our Specific Aims the study team proposes a prospective, observational pilot study of four rapid risk stratification tools, the HEART Pathway Score, EDACS score, revised Geneva score, and PERC score, among 250 chest pain patients within two large EMS systems. The proposed pilot study has broad-based support from local and state EMS agencies, including Cumberland and New Hanover County EMS agencies. Each tool will be pilot tested and compared in the prehospital setting for feasibility and accuracy. Paramedics will be trained in risk stratification tool use and then will prospectively collect the clinical data needed to calculate each risk stratification score when caring for adults with chest pain. Completed paramedic risk assessments will be used to determine feasibility. Patients will be followed for 30 days to determine occurrence of ACS and PE events and the sensitivity of each risk stratification decision aid will be determined.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 21
  • Acute non-traumatic chest pain
  • Transported by Cumberland or New Hanover County EMS to a local Emergency Department

排除标准

  • Patients with evidence of ST elevation myocardial infarction (STEMI) on ECG
  • Inter-facility transports (transfers)
  • Patients with unstable vital signs
  • Prisoners
  • Non-english speakers

结局指标

主要结局

Determine whether prehospital chest pain decision aid use is feasible.

时间窗: 24 hours

Paramedics and blinded Emergency Department providers will be complete four risk stratification tools on a convenience sample of patients with acute chest pain. Inter-rater reliability (kappa) will be determined for each tool.

次要结局

  • Compare decision aids to determine which are the most sensitive and specific(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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