REmote iSchemic Conditioning in acUtE BRAin INfarction Study

Study Overview
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Brief Summary
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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.

Official Title
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Lower Limb Ischaemic Per-conditioning in Acute Cerebral Infarction (<H6): Multicenter Randomized Study With Stratification on IV Thrombolysis and PROBE Design (Prospective Randomized Open Trial With Blinded End-Point)

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Device: Lower limb tourniquet
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With per-CID protocol<br>Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet . | Device: Lower limb tourniquet<br>* Lower limb tourniquet will be put on half thigh. The protocol will include 4 cycles of inflation cuff 110 mm Hg above systolic blood pressure followed by 4 cycles of deflation in between. The total duration of per-CID protocol will be 40 minutes (4 phases of 5 minutes inflations' of and 4 phases of 5 minutes deflations').<br>|
| Other: Without per-CID protocol<br>Usual care patients (thrombolysis or not). | Other: Usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control) | 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) | 3 months |