Frenk Lisa D S, Rahel Braim M, de Vos Cees B, van Osch Frits H M, Prestigiacomo Fabiana G, Janssen Marcel J W, Willemsen Robert T A, van 't Hof Arnoud W, Meeder Joan G
Department of Cardiology, VieCuri Medical Centre, Venlo, Netherlands
Cardiology, VieCuri Medical Centre, Venlo, Limburg, Netherlands.
BMJ Open. 2024 Dec 20;14(12):e084139. doi: 10.1136/bmjopen-2024-084139.
Ischaemic heart disease is the single most common cause of death worldwide. Traditionally, distinguishing patients with cardiac ischaemia from patients with less alarming disease, in prehospital triage of chest pain, is challenging for both general practitioners and ambulance paramedics. Less than 20% of patients with chest pain, transferred to the emergency department (ED), have an acute coronary syndrome (ACS) and the transportation and analysis at the ED of non-ACS patients result in substantial healthcare costs and a great patient burden. Advanced risk stratification, with the help of cardiac troponin measurements, seems crucial to improve prehospital diagnostic accuracy.
The URGENT 2.0 trial is a randomised controlled trial in which the primary objective is to reduce the referral of non-cardiac chest pain (NCCP) patients, using a modified HEART score including a high-sensitivity capillary point-of-care high-sensitivity cardiac troponin I measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) regular care (control group) or (2) modified HEART score analysis (intervention group) and non-referral in case of a low modified HEART score (0-3). In total, 852 patients will be included. Follow-up will be performed at 30 days, 6 months and 12 months. Both referral rates of NCCP patients and the occurrence of major adverse cardiac events are defined as primary outcome measures.
The medical ethics committee Zuyderland-Zuyd Hogeschool (Netherlands) has approved this trial (reference numbers NL71820.096.19 and METCZ20190139). Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.
ClinicalTrials.gov, NCT04904107.
缺血性心脏病是全球最常见的单一死因。传统上，在胸痛的院前分诊中，区分心脏缺血患者与病情较轻的患者对全科医生和救护人员来说都具有挑战性。转诊至急诊科（ED）的胸痛患者中，急性冠状动脉综合征（ACS）患者不到20%，非ACS患者在急诊科的转运和检查导致了高昂的医疗费用和患者负担。借助心肌肌钙蛋白检测进行高级风险分层，对于提高院前诊断准确性似乎至关重要。
URGENT 2.0试验是一项随机对照试验，其主要目标是使用改良的HEART评分（包括高灵敏度即时检测毛细血管高灵敏度心肌肌钙蛋白I测量）减少非心源性胸痛（NCCP）患者的转诊。患者由救护人员纳入，并按1:1随机分为（1）常规护理（对照组）或（2）改良HEART评分分析（干预组），改良HEART评分低（0 - 3）时不转诊。总共将纳入852名患者。将在30天、6个月和12个月时进行随访。NCCP患者转诊率和主要不良心脏事件的发生均被定义为主要结局指标。
荷兰祖德兰德 - 南荷兰应用科学大学医学伦理委员会已批准该试验（参考编号NL71820.096.19和METCZ20190139）。将从所有参与患者处获得书面知情同意书。该试验结果将在一篇主要论文以及包含亚组分析的其他论文中发表。
ClinicalTrials.gov注册号NCT04904107
