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

Contact information

Type

Scientific

Primary contact

Prof Simon Redwood

ORCID ID

Contact details

Cardiovascular Division
Rayne Institute
6th Floor
East Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

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

http://www.guysandstthomas.nhs.uk/

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

Publication citations

Editorial Notes