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Immediate coronARy angioRraphy aftEr ventricular fibrillation out-of hospital cardiac arreST
ISRCTN ISRCTN96585404
DOI 10.1186/ISRCTN96585404
ClinicalTrials.gov identifier
EudraCT number
Public title Immediate coronARy angioRraphy aftEr ventricular fibrillation out-of hospital cardiac arreST
Scientific title Immediate coronARy angioRraphy after vEntricular fibrillation out-of hospital cardiac arreST: a randomised controlled trial
Acronym ARREST
Serial number at source 1.0
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.
Lay 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 18 to 75 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 April 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
Ethics approval NREC-London Westminster (pending)
Study design Open randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiac arrest
Participants - 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
Participants - 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
Anticipated start date 01/04/2014
Anticipated end date 31/03/2017
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 350
Interventions 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
Primary outcome measure(s) All-cause mortality at 30 days
Secondary outcome measure(s) 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)
Sources of funding Guy's and St Thomas' Charity (UK) - Interventional Research Fund
Trial website
Publications
Contact name Prof  Simon  Redwood
  Address Cardiovascular Division, Rayne Institute
6th Floor, East Wing
St Thomas' Hospital
Westminster Bridge Road
  City/town London
  Zip/Postcode SE1 7EH
  Country United Kingdom
Sponsor Guy's and St Thomas' NHS Foundation Trust (UK)
  Address c/o Mrs Karen Ignatian
R&D Department
16th Floor
Guy's Tower
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
  Sponsor website: http://www.guysandstthomas.nhs.uk/
Date applied 27/08/2013
Last edited 14/11/2013
Date ISRCTN assigned 14/11/2013
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