Plain English Summary
Background and study aims
Out-of-hospital cardiac arrest (OHCA) is the leading cause of death in Europe and the United States. In most cases this is due to a blockage in a coronary artery that supplies blood to the heart (myocardial infarction). This study aims to find out whether a strategy of early transfer to a specialist centre equipped at dealing with OHCA with access to facilities to treat the cause of the arrest, including unblocking of the arteries, will improve survival compared to current standard treatment.
Who can participate?
Men and women aged over 18 who have an out-of-hospital cardiac arrest
What does the study involve?
Patients are randomly allocated to receive either the intervention or the current standard of care. Patients in the intervention group are treated with an immediate transfer to hospital with specialist services to manage a patient with cardiac arrest - this hospital is able to immediately treat a heart attack if this is found to be the cause of the cardiac arrest. Patients allocated to the standard of care group receive the current best standard of care.
What are the possible benefits and risks of participating?
The possible benefits include improved survival. There is no financial benefit. If the participants survive the cardiac arrest there is a slight risk (less than 1%) of procedure-related complications. The risks of participating do not outweigh the risks of sudden cardiac death.
Where is the study run from?
The pilot study, which is performed in a small group of patients to see if a wider scale study is possible, was run from St Thomas' Hospital, London, UK and London Ambulance Service. The main study is expected to be performed in all the major cardiac arrest centres in London: St Thomas’ Hospital, Barts Health, Hammersmith Hospital, Royal Free Hospital, St George’s hospital, King’s College Hospital, Harefield Hospital, London Ambulance Service
When is study starting and how long is it expected to run for?
The pilot study started in November 2014 and completed recruitment in February 2016. The main study will run from January 2017 until January 2020.
Who is funding the study?
Funding for the main study is still pending. The pilot study was supported by Guy’s and St. Thomas’ Charitable Foundation and Zoll Medical Corporation (unrestricted educational grant).
Who is the main contact?
1. Prof. Simon Redwood (simon.redwood@gstt.nhs.uk)
2. Dr Tiffany Patterson (tiffany.patterson@kcl.ac.uk)
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
A Randomised tRial of Expedited transfer to a cardiac arrest centre for non- ST elevation out of hospital cardiac arrest (ARREST): a randomised controlled trial
Acronym
ARREST
Study hypothesis
Current hypothesis as of 27/09/2016:
The aim is definitively determine the best post-resuscitation care pathway for patients without ST elevation on the post resuscitation ECG. We propose that changes to emergency management comprising expedited delivery to a cardiac arrest centre (CAC) 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.
Previous hypothesis:
A strategy of immediate coronary angiography after ventricular fibrillation out-of-hospital cardiac arrest confers a survival benefit compared to current standard of care.
Ethics approval
South East NRES Committee London, 02/01/2014, ref: 13/LO/1508
Study design
Open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cardiac arrest
Intervention
Current interventions as of 27/09/2016:
1. The intervention arm consists of activation of a pre-hospital triaging system (currently routinely in place for post-arrest patients with evidence of ST elevation on the ECG) with pre-alert of the cardiac arrest centre and strategic delivery of the patient to the catheter laboratory (24 hours a day, 7 days a week). They 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, this protocolised prognostication will ensure premature withdrawal of life-sustaining treatment is prevented.
2. The control arm receives standard of care
Previous interventions:
Randomisation 1:1 into two arms through telephone randomisation:
1. Intervention arm: expedited transfer to hospital, direct to heart attack centre, immediate coronary angiography +/- percutaneous coronary intervention (PCI)
2. Control arm: standard of care
Follow up: All-cause mortality at 30 days, 6 months and 1 year (mortality tracking via central NHS database).
Study Classification (Endpoint): Safety/Efficacy
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
All-cause mortality at 30 days
Secondary outcome measures
Current secondary outcome measures as of 27/09/2016:
1. Neurological status at discharge (capped at 30 days)
2. Neurological status at 3 months
3. All-cause mortality at 3, 6 and 12 months
4. The composite of in-hospital major adverse cerebrovascular or cardiovascular events (MACCE): death, re-infarction, stroke, further revascularisation, bleeding and vascular complications (capped at 30 days)
5. Quality of life (EQ-5D-5L) at 12 months
Previous secondary outcome measures:
1. All-cause mortality at 6 months and 1 year
2. Neurological status at hospital discharge, capped at 30 days
3. Major adverse cardiovascular events:
3.1. Acute myocardial infarction
3.2. Need for repeat revascularization: PCI or coronary artery bypass grafting (CABG)
3.3. Major bleeding: procedure-related complication (requiring surgery or drop in Hb >3g/dL)
Overall trial start date
01/11/2014
Overall trial end date
01/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 27/09/2016:
1. Witnessed out-of-hospital cardiac arrest
2. Return of spontaneous circulation and 12-lead electrocardiogram
3. Age 18 or over (known or presumed)
4. No obvious non-cardiac cause (trauma, drowning, suicide, drug overdose)
Previous inclusion criteria:
1. Witnessed out-of-hospital cardiac arrest
2. Absence of non-cardiac cause (trauma, drowning, intoxication)
3. Presenting rhythm: pulseless VT or VF
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (pilot); 860 (main trial)
Participant exclusion criteria
Current exclusion criteria as of 27/09/2016:
1. Criteria for ST-elevation myocardial infarction on 12-lead electrocardiogram
2. Do Not Attempt Resuscitation Order
3. Suspected pregnancy
Previous exclusion criteria:
1. ST-elevation myocardial infarction (STEMI) on 12-lead ECG in presence of return of spontaneous circulation (ROSC)
2. Pulseless electrical activity (PEA) or Asystole (non-shockable) as the only documented rhythm
3. Do Not Attempt Resuscitation Order (DNAR)
4. Suspected pregnancy
Recruitment start date
01/01/2017
Recruitment end date
01/01/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas’ Hospital
SE1 7EH
United Kingdom
Trial participating centre
Barts Health
E1 1RD
United Kingdom
Trial participating centre
Hammersmith Hospital
W12 0HS
United Kingdom
Trial participating centre
Royal Free Hospital
NW3 2QG
United Kingdom
Trial participating centre
St George’s Hospital
SW17 0QT
United Kingdom
Trial participating centre
King’s College Hospital
SE5 9RS
United Kingdom
Trial participating centre
Harefield Hospital
UB9 6JH
United Kingdom
Trial participating centre
London Ambulance Service
-
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
c/o Mrs Karen Ignatian
R&D Department
16th Floor
Guy's Tower
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charity - Interventional Research Fund
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Zoll Medical Corporation (unrestricted educational grant)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Results of the trial pilot: submitted for peer review
2. Trial protocol: on commencing main trial
Intention to publish date
01/01/2022
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30092413