REmote iSchemic Conditioning in acUtE BRAin INfarction Study "RESCUE-BRAIN"

Recruiting

Phase N/A Results N/A

Update History

14 Sep '16
Trial name was updated.
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REmote iSchemic Conditioning in acUtE BRAin INfarction Study
5 Apr '16
The Summary of Purpose was updated.
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Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first cause of acquired disability, and the 2nd cause of dementia and death. The only approved treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is mainly correlated to the final infarct size. The objective of neuroprotective treatments is to reduce the final size of the cerebral infarction. The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral ischemia by reducing the final size of cerebral infarction animal models. The per-CID corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized control trial involving 250 patients within 6 first hours of myocardial infarction and candidate for primary angioplasty.
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Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first cause of acquired disability, and the 2nd cause of dementia and death. The only approved treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is mainly correlated to the final infarct size. The objective of neuroprotective treatments is to reduce the final size of the cerebral infarction. The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral ischemia by reducing the final size of cerebral infarction animal models. The per-CID corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized control trial involving 250 patients within 6 first hours of myocardial infarction and candidate for primary angioplasty.
The eligibility criteria were updated.
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Inclusion Criteria: - Patients ≥ 18 years - Carotid ischemic stroke - NIHSS score between 5 and 25 - Brain MRI performed within 6 hours from symptoms onset - Obtaining a written informed consent of the patient or a third party (parent or close), or emergency inclusion process - Affiliated with a Medicare (or rightful beneficiary) Exclusion Criteria: - Presence of a leg ulcer or a bad skin condition in the lower limbs - History of arterial occlusive disease of the lower limbs - Sickle cell disease known (risk of vaso-occlusive crisis) - History of phlebitis in the lower limbs - History of cerebral infarction older than 3 months - Participation in another interventional acute phase protocol - Patients under guardianship - Pathologies involving life-threatening within 6 months and making it impossible to evaluate to 3 months - Patient non-self before the ischemic stroke (Rankin Score previous> 2) - Pregnant Women
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Inclusion Criteria: - Patients ≥ 18 years - Carotid ischemic stroke - NIHSS score between 4 and 25 - Brain MRI performed within 6 hours from symptoms onset - Obtaining a written informed consent of the patient or a third party (parent or close) - Affiliated with a Medicare (or rightful beneficiary) Exclusion Criteria: - Presence of a leg ulcer or a bad skin condition in the lower limbs - History of arterial occlusive disease of the lower limbs - Sickle cell disease known (risk of vaso-occlusive crisis) - History of phlebitis in the lower limbs - History of cerebral infarction older than 3 months - Participation in another interventional acute phase protocol - Patients under guardianship - Pathologies involving life-threatening within 6 months and making it impossible to evaluate to 3 months - Patient non-self before the ischemic stroke (Rankin Score previous> 2) - Pregnant Women
A location was updated in Corbeil-Essonne.
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The overall status was updated to "Recruiting" at Centre Hospitalier Sud Francilien.
A location was updated in Créteil.
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The overall status was updated to "Recruiting" at Hôpital Henri Mondor.
A location was updated in Paris.
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The overall status was updated to "Recruiting" at Hôpital Pitie-Salpêtrière.
A location was updated in Paris.
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The overall status was updated to "Recruiting" at Hôpital Bichat.
20 Feb '15
A location was updated in Le Chesnay.
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The overall status was updated to "Recruiting" at Centre Hospitalier de Versailles.