Remote ischaemic Conditioning After Stroke Trial - 3

Phase 3

• Conditions: Adults with acute ischaemic stroke presenting in Emergency Departments and Stroke Units in the UK; Circulatory System; Hyperacute ischaemic stroke

• Registration Number: ISRCTN63231313
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 8 January 2024
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

Current participant inclusion criteria as of 20/12/2023:
1. Hyperacute ischaemic stroke
2. < 24h post stroke onset
3. Primary intracerebral haemorrhage ruled out on baseline clinical neuroimaging
4. NIHSS score of 5-25 at randomisation
5. Aged 18 years or above

Previous participant inclusion criteria as of 29/04/2020 to 20/12/2023:
1. Hyperacute ischaemic stroke
2. < 6 h post stroke onset
3. Primary intracerebral haemorrhage ruled out on baseline clinical neuroimaging
4. NIHSS score of greater than 3 at randomisation
5. Aged 18 years or above

Previous participant inclusion criteria:
1. Hyperacute ischaemic stroke
2. < 6 h post stroke onset
3. Primary intracerebral haemorrhage ruled out on baseline clinical neuroimaging
4. NIHSS score > 4 at randomisation
5. Aged > 18 years

Exclusion Criteria

Current participant exclusion criteria as of 20/12/2023:
1. Pre-morbid dependency (modified Rankin Scale, mRS>3)
2. Systolic BP =80 mmHg
3. Spontaneous intracerebral haemorrhage
4. Haemorrhagic transformation of infarction PH2 if known before randomisation (not excluded or withdrawn if occurs after randomisation)
5. Dementia - if the patient had a pre-existing diagnosis
6. Coma (GCS <8)
7. Malignancy and significant co-morbidity (life expectancy <6 months)
8. BM <3.0 mmol/L
9. Seizure on presentation unless brain imaging identifies evidence of significant brain ischaemia
10. Taking part in another interventional trial, unless co-enrolment has been approved by both Chief Investigators and Sponsors
11. Known pregnancy
12. Significant tissue injury of the upper limbs, which in the opinion of the investigator, will be exacerbated by RIC
13. Expected repatriation to another hospital not participating in RECAST-3

Previous participant exclusion criteria as of 15/12/2021 to 20/12/2023:
1. Pre-morbid dependency (modified Rankin Scale, mRS>3)
2. Spontaneous intracerebral haemorrhage
3. Haemorrhagic transformation of infarction PH2
4. Dementia
5. Coma (GCS <8)
6. Malignancy and significant co-morbidity (life expectancy <6 months)
7. BM <3.0 mmol/L
8. Seizure on presentation unless brain imaging identifies evidence of significant brain ischaemia
9. Taking part in another interventional trial, unless co-enrolment has been approved by both Chief Investigators and Sponsors
10. Known pregnancy

Previous participant exclusion criteria as of 29/04/2020:
1. Pre-morbid dependency (modified Rankin Scale, mRS> 3)
2. Spontaneous intracerebral haemorrhage
3. Dementia
4. Coma (GCS < 8)
5. Malignancy
6. Significant co-morbidity (life expectancy < 6 months)
7. BM < 3.0 mmol/L
8. Seizure on presentation unless brain imaging identifies evidence of significant brain ischaemia
9. Known pregnancy

Previous participant exclusion criteria:
1. Pre-morbid dependency (modified Rankin Scale, mRS> 3)
2. Spontaneous intracerebral haemorrhage
3. Dementia
4. Coma (GCS < 8)
5. Malignancy
6. Significant co-morbidity (life expectancy < 6 months)
7. BM < 3.0 mmol/L
8. Seizure on presentation unless brain imaging identifies evidence of significant brain ischaemia
9. Long term (> 7 days) nitrate therapy
10. Receiving treatment for diabetes
11. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death or dependency assessed by the modified Rankin Scale (mRS) ordinal shift analysis recorded using central blinded telephone follow-up at 90 days.