REmote iSchemic Conditioning in acUtE BRAin INfarction Study (RESCUE-BRAIN)

• ClinicalTrials.gov Identifier: NCT02189928
• Recruitment Status: Unknown
• First Posted: July 15, 2014
• Last Update Posted: September 5, 2018
• Sponsor: Versailles Hospital
• Collaborator: Unité de Recherche Clinique Paris IDF Ouest
• Information provided by (Responsible Party): Pr Fernando PICO, Versailles Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Infarction	Device: Lower limb tourniquet; Other: Usual care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: January 2015
• Estimated Primary Completion Date: January 2019
• Estimated Study Completion Date: January 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: With per-CID protocol; Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .	Device: Lower limb tourniquet; 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').
Without per-CID protocol; Usual care patients (thrombolysis or not).	Other: Usual care

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: 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 :

1. Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control) [ Time Frame: 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)

Other Outcome Measures:

1. safety of remote perconditioning ischemic process [ Time Frame: 7 days ]
   - Rate of lower limb ischemia and deep venous thrombosis in Per CID group
2. safety of remote perconditioning ischemic process [ Time Frame: 7 days ]
   Rate of early neurological worsening (NIHSS score (d1- d0) > 4 points) in Per-CID and control group
3. safety of remote perconditioning ischemic process [ Time Frame: 7 days ]
   Percentage of hemorrhagic transformation in case of IV thrombolysis in the 2 groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Centre Hospitalier Sud Francilien

Corbeil-Essonne, France, 91100

Hôpital Henri Mondor

Créteil, France, 94000

Centre Hospitalier de Versailles

Le Chesnay, France, 78150

CHU de Nantes

Nantes, France, 44093

Hôpital Pitie-Salpêtrière

Paris, France, 75013

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France, 75019

Hôpital Bichat

Paris, France, 78018

CHU de Strasbourg

Strasbourg, France, 67098

Hôpital Foch

Suresnes, France, 92150

Sponsors and Collaborators

Versailles Hospital

Unité de Recherche Clinique Paris IDF Ouest

Investigators

• Principal Investigator: Fernando PICO, Neurology Department head; Versailles Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Pr Fernando PICO, Investigator coordinator, Versailles Hospital
• ClinicalTrials.gov Identifier: NCT02189928
• Other Study ID Numbers: P14/01_RESCUE BRAIN; 2014-A00104-43 ( Registry Identifier: ID RCB )
• First Posted: July 15, 2014
• Last Update Posted: September 5, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Cerebral Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases