NCT03872960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
862

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

5.8 years

First QC Date

March 8, 2019

Last Update Submit

May 24, 2024

Conditions

Keywords

cardiac arrestpre-hospital carestrategy trial

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    30 days after randomisation

Secondary Outcomes (8)

  • Cerebral performance category score

    Discharge (capped at 30 days)

  • Modified Rankin Score

    Discharge (capped at 30 days)

  • Cerebral performance category score

    3 months after randomisation

  • Modified Rankin Score

    3 months after randomisation

  • All-cause mortality

    3 months after randomisation

  • +3 more secondary outcomes

Study Arms (2)

Intervention Arm: Expedited transfer to a CAC

EXPERIMENTAL

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.

Procedure: Transfer to cardiac arrest centre

Control Arm: Current standard of care

NO INTERVENTION

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.

Interventions

Patients in the intervention arm will be taken directly to a the catheter lab of a heart attack centre.

Intervention Arm: Expedited transfer to a CAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Dartford and Gravesham NHS Trust

Dartford, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

BHR University Hospitals NHS Trust

London, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

Location

Croydon Health Services NHS Trust

London, United Kingdom

Location

Epsom and St Helier University Hospitals NHS Trust

London, United Kingdom

Location

Guy's and St Thomas' NHS FT

London, United Kingdom

Location

Hillingdon Hospitals NHS Trust

London, United Kingdom

Location

Homerton University Hospital NHS Trust

London, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Kingston Hospital NHS FT

London, United Kingdom

Location

Lewisham & Greenwich NHS Trust

London, United Kingdom

Location

London Ambulance Service NHS Trust

London, United Kingdom

Location

London North West University Healthcare

London, United Kingdom

Location

North Middlesex University Hospital NHS Trust

London, United Kingdom

Location

Royal Brompton and Harefield NHS Trust

London, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

Surrey and Sussex Healthcare NHS Trust

London, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Location

West Hertfordshire Hospitals NHS Trust

Watford, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 30092413BACKGROUND
  • Patterson T, Perkins GD, Perkins A, Clayton T, Evans R, Dodd M, Robertson S, Wilson K, Mellett-Smith A, Fothergill RT, McCrone P, Dalby M, MacCarthy P, Firoozi S, Malik I, Rakhit R, Jain A, Nolan JP, Redwood SR; ARREST trial collaborators. Expedited transfer to a cardiac arrest centre for non-ST-elevation out-of-hospital cardiac arrest (ARREST): a UK prospective, multicentre, parallel, randomised clinical trial. Lancet. 2023 Oct 14;402(10410):1329-1337. doi: 10.1016/S0140-6736(23)01351-X. Epub 2023 Aug 27.

Related Links

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Simon Redwood, MBBS, PhD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 13, 2019

Study Start

February 2, 2018

Primary Completion

December 4, 2023

Study Completion

April 30, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations