ISRCTN63231313进行中（未招募）3 期
Remote Ischaemic Conditioning After Stroke Trial (ReCAST- 3)
niversity of Nottingham0 个研究点目标入组 1,300 人开始时间: 2020年4月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 Haemorrhagic transformation of infarction PH2 if known before randomisation (not excluded or withdrawn if occurs after randomisation)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
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