Plain English Summary
Background and study aims
Out-of-hospital cardiac arrest is the leading cause of death in Europe and the United States. In most cases this is due to plaque rupture in a coronary artery (myocardial infarction). This study aims to find out whether a strategy for immediate coronary angiography that checks the blood supply to the heart 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 can participate in this study.
What does the study involve?
Patients will be randomly allocated to receive either the intervention or usual care. Patients in the intervention group will be treated with an immediate transfer to hospital and immediate coronary angiography with or without percutaneous coronary intervention (PCI) in the event of a cardiac arrest. If their pulse does not return, a mechanical compression device will be used to aid transfer.
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 study is run from St Thomas Hospital, London, UK.
When is study starting and how long is it expected to run for?
The study starts in November 2014. The recruitment continues until March 2016. The study will run until March 2017.
Who is funding the study?
Guy's and St Thomas' Charity (UK).
Who is the main contact?
Prof. Simon Redwood
simon.redwood@gstt.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
Immediate coronARy angioRraphy after vEntricular fibrillation out-of hospital cardiac arreST: a randomised controlled trial
Acronym
ARREST
Study 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.
On 27/10/2014 the anticipated start date was changed from 01/04/2014 to 01/11/2014.
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 below to request a patient information sheet
Condition
Cardiac arrest
Intervention
Immediate Coronary Angiography
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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
All-cause mortality at 30 days
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
31/03/2017
Reason abandoned
Eligibility
Participant 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
350
Participant 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
01/11/2014
Recruitment end date
31/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiovascular Division, Rayne Institute
London
SE1 7EH
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 (UK) - Interventional Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary