REmote iSchemic Conditioning in acUtE BRAin INfarction Study

Not Applicable

• Conditions: Cerebral Infarction

• 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

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Study Start: 2015-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

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