A randomised trial of expedited transfer to a cardiac arrest centre for non-ST elevation out of hospital cardiac arrest
| ISRCTN | ISRCTN96585404 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96585404 |
| IRAS number | 125842 |
| ClinicalTrials.gov number | NCT03872960 |
| Secondary identifying numbers | 6.0, IRAS 125842 |
- Submission date
- 27/08/2013
- Registration date
- 14/11/2013
- Last edited
- 23/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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, which includes delivery to the closest emergency department.
What are the possible benefits and risks of participating?
The possible benefits include improved survival. Participating in this study will help us to determine the best urgent care for patients who have had a cardiac arrest. 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 was 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 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, and is being run in collaboration between King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, London School of Hygiene and Tropical Medicine and the 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 April 2024.
Who is funding the study?
The pilot study was supported by Guy’s and St. Thomas’ Charitable Foundation and Zoll Medical Corporation (unrestricted educational grant).
The main study is funded by the British Heart Foundation.
Who is the main contact?
1. Prof. Simon Redwood (simon.redwood@gstt.nhs.uk)
2. Dr Tiffany Patterson (tiffany.patterson@kcl.ac.uk)
Contact information
Scientific
Cardiovascular Division, Rayne Institute
6th Floor, East Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Public
Department of Medical Statistics
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 020 7927 2723 |
|---|---|
| arrest@lshtm.ac.uk |
Study information
| Study design | Open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | ARREST |
| Study objectives | 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(s) | South East NRES Committee London, 02/01/2014, ref: 13/LO/1508 |
| Health condition(s) or problem(s) studied | Cardiac arrest |
| Intervention | Current interventions as of 02/05/2023: 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. 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. 2. 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. _____ Previous 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 |
| Primary outcome measure | All-cause mortality at 30 days |
| Secondary outcome measures | Current secondary outcome measures as of 02/05/2023: 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. Quality of life (EQ-5D-5L) at discharge (capped at 30 days) _____ Previous secondary outcome measures as of 07/03/2023: 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 discharge (capped at 30 days) _____ Previous 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 study start date | 01/11/2014 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 (pilot); 860 (main trial) |
| Key inclusion criteria | Current participant inclusion criteria as of 14/02/2020: 1. Out-of-hospital cardiac arrest (OHCA) 2. Return of spontaneous circulation (ROSC) 3. Aged 18 or over (known or presumed) Previous 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 |
| Key exclusion criteria | Current participant exclusion criteria as of 14/02/2020: 1. Criteria for ST-elevation myocardial infarction on 12-Lead electrocardiogram (ECG) 2. Do Not Attempt Resuscitation (DNAR) Order 3. Cardiac arrest suffered after care pathway set and patient en route 4. Suspected pregnancy 5. Presumed non-cardiac cause (for example; trauma, drowning, suicide, drug overdose) 6. Presumed significant trauma/injury Previous 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 |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 01/12/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mrs Karen Ignatian
R&D Department
16th Floor
Guy's Tower
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 1. Results of the trial pilot: submitted for peer review 2. Trial protocol: on commencing main trial |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2018 | Yes | No | |
| Other publications | pilot study | 01/06/2017 | 17/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 14/10/2023 | 23/07/2024 | Yes | No | |
| Statistical Analysis Plan | Supplementary appendix | 14/10/2023 | 23/07/2024 | No | No |
Additional files
- ISRCTN96585404 ARREST Supplementary appendix 14.10.23.pdf
- Supplementary appendix
Editorial Notes
23/07/2024: The following changes were made to the trial record:
1. Publication reference added.
2. A supplementary appendix including the statistical analysis plan was uploaded as an additional file.
02/05/2023: The following changes were made to the trial record:
1. The interventions were changed.
2. The secondary outcome measures were changed.
3. The funder was changed from "Guy's and St Thomas' Charity - Interventional Research Fund, and Zoll Medical Corporation (unrestricted educational grant)" to "British Heart Foundation"
4. The plain English summary was updated to reflect these changes.
07/03/2023: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The recruitment end date was changed from 31/10/2022 to 01/12/2022.
3. The overall end date was changed from 31/10/2023 to 30/04/2024.
22/07/2022: The public contact has been changed.
06/04/2022: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2023 to 31/10/2023 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 30/04/2022 to 30/04/2024.
10/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 31/10/2022.
2. The overall trial end date has been changed from 30/04/2022 to 30/04/2023 and the plain English summary has been updated to reflect this change.
16/10/2020: The following changes were made to the trial record:
1. The recruitment resumed.
2. The recruitment end date was changed from 31/10/2020 to 30/06/2021.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
17/02/2020: The following changes have been made:
1. Publication reference added.
2. The IRAS number has been added.
3. The public contact has been added.
14/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 01/01/2021 to 30/04/2022.
2. The overall trial end date has been changed from 01/01/2020 to 31/10/2020.
3. The intention to publish date has been changed from 01/01/2022 to 30/04/2022.
4. The trial website has been added.
5. The participant inclusion criteria have been updated.
6. The participant exclusion criteria have been updated.
7. The plain English summary has been updated to reflect the changes above.
16/08/2019: ClinicalTrials.gov number added.
10/08/2018: Publication reference added.
27/09/2016: The following changes were made to the trial record:
1. The title was changed from 'Immediate coronARy angioRraphy aftEr ventricular fibrillation out-of hospital cardiac arreST' to 'A Randomised tRial of Expedited transfer to a cardiac arrest centre for non- ST elevation out of hospital cardiac arrest'
2. The overall trial end date was changed from 31/03/2017 to 01/01/2021.
3. The target number of participants was changed from '350' to '40 (pilot); 860 (main trial)'
27/10/2014: The overall trial start date was changed from 01/04/2014 to 01/11/2014.
