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通过 HEART 评分评估和单点即时检测肌钙蛋白在(院前)环境中对非 ST 段抬高型急性冠脉综合征的急性排除:ARTICA 随机试验的原理和设计。

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: rationale and design of the ARTICA randomised trial.

机构信息

Cardiology, Radboudumc, Nijmegen, The Netherlands.

Ambulancezorg, Veiligheidsregio Gelderland-Zuid, Nijmegen, The Netherlands.

出版信息

BMJ Open. 2020 Feb 17;10(2):e034403. doi: 10.1136/bmjopen-2019-034403.

Abstract

INTRODUCTION

Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective.

METHODS AND ANALYSIS

The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months.

ETHICS AND DISSEMINATION

This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.

TRIAL REGISTRATION NUMBER

Netherlands Trial Register (NL7148).

摘要

简介

由于缺乏排除非 ST 段抬高型急性冠状动脉综合征(NSTE-ACS)的院前方案,胸痛患者经常被转往急诊科(ED)进行全面评估。然而,在低危患者中,很少发现 ACS,导致不必要的医疗保健消耗。使用 HEART(病史、心电图、年龄、危险因素和肌钙蛋白)评分,可以轻松识别低危患者。当将床边肌钙蛋白测量纳入 HEART 评分中时,可以在院前环境中充分排除低危患者的 ACS。然而,在疑似 NSTE-ACS 的患者中,使用 HEART 评分和床边肌钙蛋白测量进行院前排除策略是否具有成本效益,目前仍不清楚。

方法和分析

ARTICA 试验是一项随机试验,主要目的是在 30 天内,调查疑似 NSTE-ACS 的低危患者使用改良的 HEART 评分(包括床边肌钙蛋白 T 测量)进行早期排除策略的成本效益。通过救护车护理人员纳入患者,并按照 1:1 随机分为(1)就诊于 ED(对照组)或(2)床边肌钙蛋白 T 测量(干预组),并在肌钙蛋白 T 值较低的情况下将护理转交给全科医生。总共将纳入 866 名患者。将在 30 天后、6 个月和 12 个月进行随访。

伦理和传播

该试验已被 Arnhem-Nijmegen 医学研究伦理委员会接受。该试验的结果将以一篇主要论文和具有亚组分析的额外论文进行传播。

试验注册号

荷兰试验注册处(NL7148)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b672/7044902/b380f92c73fb/bmjopen-2019-034403f01.jpg

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