跳至主要内容
临床试验/NCT05466591
NCT05466591Unknown不适用

Acute Rule Out of Non ST-segment Elevation Acute Coronary Syndrome in the (Pre)Hospital Setting by HEART Score Assessment and a Single Point-of-care Troponin

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 866 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
866
试验地点
2
主要终点
Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)

研究概览

简要总结

Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is not necessary. The ARTICA trial aims to assess the healthcare cost reduction and safety of a pre-hospital rule-out strategy using a single POC troponin measurement.

详细描述

Patients with chest pain suspected of a NSTE-ACS are screened by ambulance paramedics. The HEAR score (HEART score without the Troponin component) is assessed and patients with a HEAR score of ≤3 are included. The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group). Primary outcome is healthcare costs after 30 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The clinical events are blindly adjudicated by an independent Clinical Events Committee

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)

时间窗: 30 days

Healthcare costs consist of all costs related to healthcare consumption

次要结局

  • Safety: all cause death, acute coronary syndrome, unplanned revascularisation(30 days)
  • Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)(30 days)
  • Safety (all cause death, acute coronary syndrome, unplanned revascularisation)(12 months)

研究者

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

Cyril Camaro

Principal Investigator

Radboud University Medical Center

研究点 (2)

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