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

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ClinicalTrials.gov Identifier: NCT02189928
Recruitment Status : Unknown
Verified September 2018 by Pr Fernando PICO, Versailles Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2014
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Unité de Recherche Clinique Paris IDF Ouest
Information provided by (Responsible Party):
Pr Fernando PICO, Versailles Hospital

Study Description
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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
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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
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189928


Locations
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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
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Principal Investigator: Fernando PICO, Neurology Department head Versailles Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
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:
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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