Clinical trial NCT02189928: REmote iSchemic Conditioning in acUtE BRAin INfarction Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Infarction
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Unité de Recherche Clinique Paris IDF Ouest
First posted: 2014-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control)
timeFrame: 3 months
Other outcomes:
measure: safety of remote perconditioning ischemic process
timeFrame: 7 days
measure: safety of remote perconditioning ischemic process
timeFrame: 7 days
measure: safety of remote perconditioning ischemic process
timeFrame: 7 days
Locations:
city: Corbeil-Essonne
country: France
facility: Centre Hospitalier Sud Francilien
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Pitie-Salpêtrière
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Paris
country: France
facility: Hôpital Bichat
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Versailles Hospital
name: Fernando PICO, Neurology Department head
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pico F, Lapergue B, Ferrigno M, Rosso C, Meseguer E, Chadenat ML, Bourdain F, Obadia M, Hirel C, Duong DL, Deltour S, Aegerter P, Labreuche J, Cattenoy A, Smadja D, Hosseini H, Guillon B, Wolff V, Samson Y, Cordonnier C, Amarenco P. Effect of In-Hospital Remote Ischemic Perconditioning on Brain Infarction Growth and Clinical Outcomes in Patients With Acute Ischemic Stroke: The RESCUE BRAIN Randomized Clinical Trial. JAMA Neurol. 2020 Jun 1;77(6):725-734. doi: 10.1001/jamaneurol.2020.0326.
citation: Pico F, Rosso C, Meseguer E, Chadenat ML, Cattenoy A, Aegerter P, Deltour S, Yeung J, Hosseini H, Lambert Y, Smadja D, Samson Y, Amarenco P. A multicenter, randomized trial on neuroprotection with remote ischemic per-conditioning during acute ischemic stroke: the REmote iSchemic Conditioning in acUtE BRAin INfarction study protocol. Int J Stroke. 2016 Oct;11(8):938-943. doi: 10.1177/1747493016660098. Epub 2016 Jul 19.