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

Primary Purpose

Out-Of-Hospital Cardiac Arrest

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transfer to cardiac arrest centre
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest focused on measuring cardiac arrest, pre-hospital care, strategy trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Out-of-hospital cardiac arrest (OHCA)
  • Return of spontaneous circulation (ROSC)
  • Age 18 or over (known or presumed)
  • Absence of non-cardiac cause (for example; trauma, drowning, suicide, drug overdose)

Exclusion Criteria:

  • 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

Sites / Locations

  • Dartford and Gravesham NHS Trust
  • Barts Health NHS Trust
  • BHR University Hospitals NHS Trust
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • Croydon Health Services NHS Trust
  • Epsom and St Helier University Hospitals NHS Trust
  • Guy's and St Thomas' NHS FT
  • Hillingdon Hospitals NHS Trust
  • Homerton University Hospital NHS Trust
  • Imperial College Healthcare NHS Trust
  • King's College Hospital NHS Foundation Trust
  • Kingston Hospital NHS FT
  • Lewisham & Greenwich NHS Trust
  • London Ambulance Service NHS Trust
  • London North West University Healthcare
  • North Middlesex University Hospital NHS Trust
  • Royal Brompton and Harefield NHS Trust
  • Royal Free London NHS Foundation Trust
  • St George's University Hospitals NHS Foundation Trust
  • Surrey and Sussex Healthcare NHS Trust
  • University College London Hospitals NHS Foundation Trust
  • West Hertfordshire Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm: Expedited transfer to a CAC

Control Arm: Current standard of care

Arm Description

The intervention arm consists of activation of the pre-hospital triaging system currently in place for post-arrest STE patients. This involves pre-alert of the CAC and strategic delivery of the patient to the catheter laboratory (24 hours a day, 7 days a week). Patients will receive definitive post-resuscitation care: intubation and ventilation, where necessary, targeted temperature management, and goal directed therapies including evaluation and identification of underlying cause of arrest with access to immediate reperfusion if necessary. Prognostication will occur no earlier than 72 hours post-cardiac arrest to prevent premature withdrawal of life-sustaining treatment. Transfer times estimated from the 40-patient pilot are anticipated to be 100 minutes (median; IQR 75 to 113) from time of arrest to the designated centre.

The control arm comprises the current standard of pre-hospital advanced life support (ALS) care management for patients with ROSC following cardiac arrest of suspected cardiac aetiology. The patient is conveyed to the geographically closest emergency department. Management thereafter will be as per standard hospital protocols however as in the intervention arm, prognostication is to be delayed in trial patients until at least 72 hours post arrest.

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

Cerebral performance category score
Neurological status assessed using the cerebral performance category (ranked scale from 1 to 5 with 1 being the best outcome and 5 the worse outcome)
Modified Rankin Score
Neurological status assessed using the modified Ranking Score (ranked scale from 0 to 6 with 0 being the better outcome and 6 the worse outcome).
Cerebral performance category score
Neurological assessed using the cerebral performance category (ranked scale from 1 to 5 with 1 being the best outcome and 5 the worse outcome)
Modified Rankin Score
Neurological status assessed using the modified Ranking Score (ranked scale from 0 to 6 with 0 being the better outcome and 6 the worse outcome).
All-cause mortality
All-cause mortality
All-cause mortality
Patient's quality of life
Assessed using the EuroQol-5 Dimension-5 Level (EQ-5D-5L) standardised survey

Full Information

First Posted
March 8, 2019
Last Updated
May 3, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London, London School of Hygiene and Tropical Medicine, Barts & The London NHS Trust, King's College Hospital NHS Trust, Imperial College Healthcare NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, London Ambulance Service NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03872960
Brief Title
A Randomised Trial of Expedited Transfer to a Cardiac Arrest Centre for Non-ST Elevation Out-of-hospital Cardiac Arrest
Acronym
ARREST
Official Title
A Randomised Trial of Expedited Transfer to a Cardiac Arrest Centre for Non-ST Elevation Out-of-hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London, London School of Hygiene and Tropical Medicine, Barts & The London NHS Trust, King's College Hospital NHS Trust, Imperial College Healthcare NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, London Ambulance Service NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. The two arms are as follows: Intervention Arm: Direct to CAC The intervention arm consists of activation of the pre-hospital triaging system currently in place for post-arrest STE patients. This involves pre-alert of the CAC and strategic delivery of the patient to the catheter laboratory (24 hours a day, 7 days a week). Patients will receive definitive post-resuscitation care: intubation and ventilation, where necessary, targeted temperature management, and goal directed therapies including evaluation and identification of underlying cause of arrest with access to immediate reperfusion if necessary. Prognostication will occur no earlier than 72 hours post-cardiac arrest to prevent premature withdrawal of life-sustaining treatment. Transfer times estimated from the 40-patient pilot are anticipated to be 100 minutes (median; IQR 75 to 113) from time of arrest to the designated centre. Control Arm: Standard of Care The control arm comprises the current standard of pre-hospital advanced life support (ALS) care management for patients with ROSC following cardiac arrest of suspected cardiac aetiology. The patient is conveyed to the geographically closest emergency department. Management thereafter will be as per standard hospital protocols however as in the intervention arm, prognostication is to be delayed in trial patients until at least 72 hours post arrest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
cardiac arrest, pre-hospital care, strategy trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm: Expedited transfer to a CAC
Arm Type
Experimental
Arm Description
The intervention arm consists of activation of the pre-hospital triaging system currently in place for post-arrest STE patients. This involves pre-alert of the CAC and strategic delivery of the patient to the catheter laboratory (24 hours a day, 7 days a week). Patients will receive definitive post-resuscitation care: intubation and ventilation, where necessary, targeted temperature management, and goal directed therapies including evaluation and identification of underlying cause of arrest with access to immediate reperfusion if necessary. Prognostication will occur no earlier than 72 hours post-cardiac arrest to prevent premature withdrawal of life-sustaining treatment. Transfer times estimated from the 40-patient pilot are anticipated to be 100 minutes (median; IQR 75 to 113) from time of arrest to the designated centre.
Arm Title
Control Arm: Current standard of care
Arm Type
No Intervention
Arm Description
The control arm comprises the current standard of pre-hospital advanced life support (ALS) care management for patients with ROSC following cardiac arrest of suspected cardiac aetiology. The patient is conveyed to the geographically closest emergency department. Management thereafter will be as per standard hospital protocols however as in the intervention arm, prognostication is to be delayed in trial patients until at least 72 hours post arrest.
Intervention Type
Procedure
Intervention Name(s)
Transfer to cardiac arrest centre
Intervention Description
Patients in the intervention arm will be taken directly to a the catheter lab of a heart attack centre.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days after randomisation
Secondary Outcome Measure Information:
Title
Cerebral performance category score
Description
Neurological status assessed using the cerebral performance category (ranked scale from 1 to 5 with 1 being the best outcome and 5 the worse outcome)
Time Frame
Discharge (capped at 30 days)
Title
Modified Rankin Score
Description
Neurological status assessed using the modified Ranking Score (ranked scale from 0 to 6 with 0 being the better outcome and 6 the worse outcome).
Time Frame
Discharge (capped at 30 days)
Title
Cerebral performance category score
Description
Neurological assessed using the cerebral performance category (ranked scale from 1 to 5 with 1 being the best outcome and 5 the worse outcome)
Time Frame
3 months after randomisation
Title
Modified Rankin Score
Description
Neurological status assessed using the modified Ranking Score (ranked scale from 0 to 6 with 0 being the better outcome and 6 the worse outcome).
Time Frame
3 months after randomisation
Title
All-cause mortality
Time Frame
3 months after randomisation
Title
All-cause mortality
Time Frame
6 months after randomisation
Title
All-cause mortality
Time Frame
12 months after randomisation
Title
Patient's quality of life
Description
Assessed using the EuroQol-5 Dimension-5 Level (EQ-5D-5L) standardised survey
Time Frame
Discharge (capped at 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Out-of-hospital cardiac arrest (OHCA) Return of spontaneous circulation (ROSC) Age 18 or over (known or presumed) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Redwood, MBBS, PhD
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartford and Gravesham NHS Trust
City
Dartford
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Facility Name
BHR University Hospitals NHS Trust
City
London
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Croydon Health Services NHS Trust
City
London
Country
United Kingdom
Facility Name
Epsom and St Helier University Hospitals NHS Trust
City
London
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS FT
City
London
Country
United Kingdom
Facility Name
Hillingdon Hospitals NHS Trust
City
London
Country
United Kingdom
Facility Name
Homerton University Hospital NHS Trust
City
London
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Kingston Hospital NHS FT
City
London
Country
United Kingdom
Facility Name
Lewisham & Greenwich NHS Trust
City
London
Country
United Kingdom
Facility Name
London Ambulance Service NHS Trust
City
London
Country
United Kingdom
Facility Name
London North West University Healthcare
City
London
Country
United Kingdom
Facility Name
North Middlesex University Hospital NHS Trust
City
London
Country
United Kingdom
Facility Name
Royal Brompton and Harefield NHS Trust
City
London
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Surrey and Sussex Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
West Hertfordshire Hospitals NHS Trust
City
Watford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30092413
Citation
Patterson T, Perkins A, Perkins GD, Clayton T, Evans R, Nguyen H, Wilson K, Whitbread M, Hughes J, Fothergill RT, Nevett J, Mosweu I, McCrone P, Dalby M, Rakhit R, MacCarthy P, Perera D, Nolan JP, Redwood SR. Rationale and design of: A Randomized tRial of Expedited transfer to a cardiac arrest center for non-ST elevation out-of-hospital cardiac arrest: The ARREST randomized controlled trial. Am Heart J. 2018 Oct;204:92-101. doi: 10.1016/j.ahj.2018.06.016. Epub 2018 Aug 6.
Results Reference
background
Links:
URL
http://arrest.lshtm.ac.uk/
Description
ARREST Trial Website

Learn more about this trial

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

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