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临床试验/NCT05243485
NCT05243485已完成不适用

Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study

Catharina Ziekenhuis Eindhoven1 个研究点 分布在 1 个国家目标入组 1,071 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,071
试验地点
1
主要终点
Time from first medical contact to final invasive diagnostics and revascularization

研究概览

简要总结

With the Emergency Medical Services (EMS), no prehospital risk stratification and triage is performed for patients suspected of having an Non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS). While the latest ESC Guidelines recommend an early invasive strategy within 24 hours for all high risk NSTE-ACS patients and same-day transfer to a PCI (Percutaneous Coronary Intervention) center. With the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an NSTE-ACS. The recently validated PreHEART score makes it possible to stratify patients in a low-risk and high-risk group for having a NSTE-ACS and gives the EMS the opportunity to make triage decisions in the prehospital setting. Patients with a high risk for having an NSTE-ACS are transferred directly to an PCI-center for further diagnostic work-up. Patients with a low risk for having NSTE-ACS and transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up, resulting in an optimization of the regional care utilization.

This is the first study to focus on patients who are at a high risk of having an NSTE-ACS and to assess if whether prehospital triage using the PreHEART score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.

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

  • Chest pain suspected for NSTE-ACS
  • Age ≥ 18 years
  • Intention to transfer patient to Emergency Department

排除标准

  • ST-segment elevation Acute Coronary Syndrome
  • Post resuscitation patients
  • Hemodynamic instability defined as Killip Class IV
  • Suspected other life treating pathology
  • Pregnancy
  • No informed consent for data usage

结局指标

主要结局

Time from first medical contact to final invasive diagnostics and revascularization

时间窗: Time from first medical contact by EMS to final invasive diagnostics and revascularization, up to 60 days

Duration of time from first medical contact (in the EMS) to final invasive diagnostics and revascularization

次要结局

  • Number of participants with ischemic complications(2 years)
  • Number of participants with safety endpoints during invasive diagnostics and/or revascularization(During hospitalization, up to 60 days)
  • Logistics during hospitalization(30 days)
  • Number of participants who suffer all cause death(1 and 2 years)
  • Number of participants with Major Adverse Cardiac Events(7 and 30 days)
  • Economic endpoints(During hospitalization, up to 60 days)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pieter-Jan Vlaar

Principal investigator

Catharina Ziekenhuis Eindhoven

研究点 (1)

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