REmote iSchemic Conditioning in acUtE BRAin INfarction Study
- Conditions
- Cerebral Infarction
- Interventions
- Device: Lower limb tourniquetOther: Usual care
- Registration Number
- NCT02189928
- Lead Sponsor
- Versailles Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description With per-CID protocol Lower limb tourniquet Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet . Without per-CID protocol Usual care Usual care patients (thrombolysis or not).
- Primary Outcome Measures
Name Time Method Brain MRI changes of DWI ( Diffusion-Weighted Imaging) brain infarction volume (cc) between baseline (<H6) and day 1 in the 2 groups of patients ( Remote Ischemic Perconditioning and control) 24 hours Central lecture of brain MRI, blinded to clinical data, randomisation group and day of MRI realization ( day 0 or day 1) Endpoint criteria: DWI volume d1-d0 (cc) measured by a dedicated software (Neurinfarct) Comparison of DWI volume d1-d0 between the 2 groups ( Per-CID group and control)
- Secondary Outcome Measures
Name Time Method Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control) 3 months Percentage of patients with Modified Rankin Scale (mRS) \<2 ( i.e. favorable outcome with no disability) at 3 months in the 2 groups (PerCID and control)
Trial Locations
- Locations (9)
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonne, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Centre Hospitalier de Versailles
🇫🇷Le Chesnay, France
CHU de Nantes
🇫🇷Nantes, France
Fondation Ophtalmologique Adolphe de Rothschild
🇫🇷Paris, France
Hôpital Bichat
🇫🇷Paris, France
CHU de Strasbourg
🇫🇷Strasbourg, France
Hôpital Foch
🇫🇷Suresnes, France
Hôpital Pitie-Salpêtrière
🇫🇷Paris, France