Remote ischaemic Conditioning After Stroke Trial - 3

Plain English Summary

Background and study aims
Strokes are very common with ~100 000 strokes occurring every year in the UK. The majority (80%) are caused by a blocked blood vessel and others are caused by a ruptured blood vessel. There are very few treatments for strokes, such as using medicines or wires to unblock blood vessels, but they can only be used in a small proportion of strokes caused by blocked blood vessels.
A treatment called ‘remote ischaemic conditioning’ (RIC) could help protect the brain from damage caused by stroke. RIC is performed by inflating a blood pressure cuff on the arm, briefly interrupting its blood supply; the cuff is deflated after 5 minutes and repeated 4 times. The process causes body chemicals to be released into the bloodstream which have a protective effect on the brain and may reduce the size of the stroke and reduce disability – this has been shown in experimental models of stroke but the treatment has not been proven in humans.

We have completed a small trial of 26 stroke patients (called RECAST-1) who used RIC soon after their stroke - RIC was very well tolerated and caused minimal side effects. We have also completed a second trial (RECAST-2) of 60 stroke patients showing we can perform RIC urgently within 6 hours of new stroke symptoms. The trial has also suggested that RIC may be able to prevent ongoing damage caused by stroke.

We plan to perform a trial across 60 UK hospitals including 1300 stroke patients called RECAST-3. Half of the participants will receive RIC, and the other half will have a sham procedure performed (a placebo). Patients will be identified and invited to take part in the trial by the Stroke Team as soon as they arrive in the hospital. The participants will have a 50:50 chance of receiving RIC or the sham procedure. RIC or sham is performed twice a day for up to 14 days (28 doses). Consent can be given by a relative or carer if the patient is not able to give it themselves. This will occur at the same time as routine treatments (such as receiving clot-busting medicine). The participant will be invited to take part in other parts of the study, including additional brain scans looking at the size of the stroke and blood tests (measuring blood proteins). The participant will be seen again by the research team on the 14th day after recruitment into the trial to answer questions on the trial treatment. After discharge from the hospital, the participant will be contacted over the telephone 3 months later to answer questions about their physical ability, mood, memory and quality of life.

New treatments will likely have their greatest effect if administered in the first few hours after a stroke. RIC is an attractive potential treatment since it would be simple and cheap to administer by medics, other healthcare professionals (nurses, paramedics) or even non-medically trained personnel. If this study shows that RIC is beneficial in reducing stroke recurrence and leading to a lower level of disability, it would have significant social, medical and financial benefits to patients, families and society.

Who can participate?
Patients at one of the participating hospitals who have a diagnosis of an ischaemic (blocked blood vessel) stroke. Patients who are over 18 years old and within 48 hours of their stroke starting will be included.

What does the study involve?
Patients who have been diagnosed with a stroke will be recruited to the study in the hospital.

Participants will either receive a treatment called ‘remote ischaemic conditioning’ (RIC) or a sham treatment. RIC is performed by inflating bilateral blood pressure cuffs on both arms, briefly interrupting the blood supply; the cuffs are deflated after 5 minutes and repeated 4 times. Participants will receive this treatment up to 28 times within 14 days of the onset of their stroke.

Participants will be assessed by doctors while in the hospital and will have a follow-up assessment by telephone call after 90 days.

What are the possible benefits and risks of participating?
We cannot promise the study will help participants but it might help reduce how badly the current stroke affects participants or it might reduce the chances of having another stroke. The information we get from this study will help in deciding the best treatments for future stroke patients.

The main disadvantage is that participants may experience some discomfort when the blood pressure cuff is kept inflated. There is a small risk that prolonged cuff inflation could cause bruising or bleeding under the skin of the participant's arm and this will be monitored closely.

Participants in the study may have a second CT brain scan on day 2, which is arranged as part of their routine care depending on the treatment already received. This procedure uses ionising radiation to form images of the head and provide the doctor with clinical information. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their lives. Standard care scans performed whilst taking part in this study will increase the chances of this happening to participants from 50% to 50.02%.

Where is the study run from?
The study is run by the University of Nottingham (UK) and will take place at 60 hospitals in the UK

When is the study starting and how long is it expected to run for?
From April 2020 to September 2026

Who is funding the study?
The National Institute for Health Research (UK)

Who is the main contact?
Mrs Diane Harvard
diane.havard@nottingham.ac.uk

Study website

Contact information

Mrs Diane Havard
Public

Stroke Trials Unit
Mental Health & Clinical Neurosciences
University of Nottingham
D Floor, South Block, Room 2151
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

ORCID ID	0000-0002-3257-1137
Phone	+44 0115 823 1775
Email	diane.havard@nottingham.ac.uk

Prof Tim England
Scientific

Vascular Medicine
Division of Medical Sciences & GEM
University of Nottingham
Royal Derby Hospital Centre
Derby
DE22 3DT
United Kingdom

ORCID ID	0000-0001-5330-8584
Phone	+44 1332 724668
Email	timothy.england@nottingham.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Nottingham
University/education

E-Floor
Yang Fujia Building
Wollaton Road
Nottingham
NG8 1BB
England
United Kingdom

Phone	0115 846 7906
Email	angela.shone@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Not defined

Results and Publications

Study outputs

Editorial Notes

09/04/2025: The following changes were made:
1. The IRAS number was changed from 282606 to 277021.
2. The interventions and participant inclusion and exclusion, criteria were changed.
06/11/2024: East Surrey Hospital was removed from the study participating centres.
20/12/2023: The following changes were made following a period of pause due to challenges in obtaining a suitable device and the plain English summary was updated to reflect these changes:
1. The overall study end date was changed from 31/12/2026 to 30/09/2026.
2. The condition was changed from "Adults with hyperacute ischaemic stroke presenting in Emergency Departments and Stroke Units in the UK" to "Adults with acute ischaemic stroke presenting in Emergency Departments and Stroke Units in the UK".
3. The interventions were changed.
4. The device name was added
5. The participant inclusion criteria were changed.
6. The participant exclusion criteria were changed.
7. The recruitment end date was changed from 31/12/2026 to 30/09/2026.
8. The intention to publish date was changed from 30/09/2026 to 31/03/2027.
05/06/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2023 to 01/01/2024.
2. The recruitment end date was changed from 28/02/2026 to 31/12/2026.
3. The overall end date was changed from 29/05/2026 to 31/12/2026.
18/01/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 29/10/2025 to 29/05/2026.
2. The intention to publish date was changed from 31/12/2025 to 30/09/2026.
12/01/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2023 to 01/06/2023.
2. The recruitment end date was changed from 31/07/2025 to 28/02/2026.
08/11/2022: The recruitment start date was changed from 01/11/2022 to 01/03/2023.
15/09/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 30/04/2022 to 01/11/2022.
2. The recruitment end date was changed from 30/01/2025 to 31/07/2025.
3. The overall trial end date was changed from 30/04/2025 to 29/10/2025.
4. The intention to publish date was changed from 30/06/2025 to 31/12/2025.
3. Arrowe Park Hospital, Edith Cavell Hospital, Southmead Hospital, Ulster Hospital, Gartnavel Royal Hospital, Royal London Hospital, Altnagelvin Hospital, Poole Hospital, Musgrove Park Hospital, South West Acute Hospital, Royal Victoria Hospital, King's Mill Hospital, Pinderfields Hospital, Royal Stoke Hospital were removed as trial participating centres.
4. The contact and sponsor details were updated.
21/03/2022: Nottingham City Hospital has been removed from the trial participating centres and Queen's Medical Centre, University College Hospital, St. George's Hospital, Dorset County Hospital, Leeds General Infirmary, Bradford Royal Infirmary, Leighton Hospital, Northumbria Specialist Emergency Care Hospital, Royal Hallamshire Hospital, Sunderland Royal Hospital, East Surrey Hospital, University Hospital Monklands, Fairfield General Hospital, Russells Hall Hospital, Royal Infirmary of Edinburgh, Epsom General Hospital, The Royal Berkshire Hospital and Torbay Hospital added.




18/03/2022: The public contact's details have been changed.
17/02/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/02/2022 to 30/04/2022.
2. The recruitment end date was changed from 01/11/2024 to 30/01/2025.
3. The intention to publish date was changed from 01/12/2025 to 30/06/2025.
15/12/2021: The following changes were made to the trial record:
1. T/he ethics details were updated.
2. The overall end date was changed from 31/12/2023 to 30/04/2025.
3. The trial website was added.
4. The exclusion criteria were changed.
5. The recruitment start date was changed from 01/07/2020 to 01/02/2022.
6. The recruitment end date was changed from 01/07/2023 to 01/11/2024.
7. The intention to publish date was changed from 01/12/2023 to 01/12/2025.
8. The plain English summary was updated to reflect these changes.
29/04/2020: The inclusion and exclusion criteria were updated.
14/04/2020: Trial's existence confirmed by the NIHR.