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临床试验/NCT03872960
NCT03872960已完成不适用

A Randomised Trial of Expedited Transfer to a Cardiac Arrest Centre for Non-ST Elevation Out-of-hospital Cardiac Arrest

Guy's and St Thomas' NHS Foundation Trust22 个研究点 分布在 1 个国家目标入组 862 人开始时间: 2018年2月2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
862
试验地点
22
主要终点
All-cause mortality

研究概览

简要总结

The aim of ARREST is to determine the best post-resuscitation care pathway for out of hospital cardiac arrest patients without ST-segment elevation. The investigators propose that changes to emergency management comprising expedited delivery to a specialist heart attack centre with organised post-cardiac arrest care including immediate access to reperfusion therapy will reduce mortality in patients without STE compared to the current standard of care, which comprises protracted pre-hospital management of the patient without definitive care plan and delivery to geographically closest hospital.

详细描述

Out-of-hospital cardiac arrest (OHCA) is a global public health issue. There are 60,000 cardiac arrests per year in the United Kingdom (UK), of which resuscitation is attempted in just under half. Resuscitation attempts are successful in up to 30%. However, more than two thirds of patients who survive to hospital admission die before discharge. There is wide variation in both regional and inter-hospital survival rates from OHCA; this disparity is also present across London. This variation has been shown to be attributable to hospital infrastructure, resources and personnel rather than patient characteristics. Overall survival therefore remains poor, at 7%.

It is well known that the majority of OHCA are secondary to an acute cardiac ischaemic event. Coronary artery disease is responsible for more than 70% of OHCA of presumed cardiac cause, with acute occlusion demonstrated in 50% of consecutive patients taken for immediate coronary angiography (ICA). Early cardiopulmonary resuscitation (CPR) and defibrillation, with ICA and percutaneous coronary intervention (PCI) in a cardiac arrest centre (CAC), prevents re-arrest, preserves myocardial function and has been shown to improve post-arrest outcomes in ST-segment elevation (STE). The management of patients without STE however is controversial, with a delayed approach to intervention. Despite recently published data suggesting PCI in non-STE resulted in a two-fold increase in favourable outcome, randomised data are lacking. Emergent reperfusion therapies come with a weak recommendation from the International Liaison Committee on Resuscitation (ILCOR), and a Class IIa recommendation by the American Heart Association (AHA) and European Society of Cardiology (ESC), if there is a high suspicion of ongoing infarction.

The European Association of Percutaneous Cardiovascular Interventions (EAPCI) recommends a prior rule-out of non-cardiac cause in the emergency department followed by coronary angiography within 2 hours. It remains unclear if time-critical, definitive hospital based management of the post-arrest patient without STE in a specialist centre improves outcomes, and there has been variable uptake of this strategy both pre-hospital and amongst the interventional cardiology community.

There is an urgent need for a randomised controlled trial examining the benefits of early delivery of post-cardiac arrest care in specialist centres, specifically in the absence of STE. Post-arrest care is time-critical, requires a multi-disciplinary approach and may be more optimally delivered in centres with greater provider experience. ILCOR and the EAPCI state that randomised trials are essential in this population to determine if timely delivery by the ambulance services to a CAC with organised postcardiac arrest care including immediate access to reperfusion therapy improves survival. There are no randomised trials and only indirect evidence that CAC and systems of care may be effective and only two observational studies examining the role of immediate ICA±PCI in the absence of STE. This is an important and topical question as there is a drive to regionalise care for all patients into CACs.

To address this, ARREST will enroll 860 OHCA patients with ROSC to a randomised clinical trial. Each arm of the trial will include 430 patients.

研究设计

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

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

  • Out-of-hospital cardiac arrest (OHCA)
  • Return of spontaneous circulation (ROSC)
  • Age 18 or over (known or presumed)

排除标准

  • Criteria for ST-elevation myocardial infarction on 12-Lead electrocardiogram (ECG)
  • Do Not Attempt Resuscitation (DNAR) Order
  • Cardiac arrest suffered after care pathway set and patient en route
  • Suspected pregnancy
  • Presumed non-cardiac cause (for example; trauma, drowning, suicide, drug overdose)
  • Presumed significant trauma/injury

结局指标

主要结局

All-cause mortality

时间窗: 30 days after randomisation

次要结局

  • Modified Rankin Score(3 months after randomisation)
  • Cerebral performance category score(3 months after randomisation)
  • All-cause mortality(12 months after randomisation)
  • Patient's quality of life(Discharge (capped at 30 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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