REmote iSchemic Conditioning in acUtE BRAin INfarction Study

Versailles Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Cerebral Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Hôpital Pitie-Salpêtrière

Paris, France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Hôpital Bichat

Paris, France

CHU de Strasbourg

Strasbourg, France

Hôpital Foch

Suresnes, France

Outcomes

Primary Outcomes

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)

Time frame: 24 hours

Secondary Outcomes

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)

Time frame: 3 months