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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

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE July 15, 2014
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
  • safety of remote perconditioning ischemic process [ Time Frame: 7 days ]
    - Rate of lower limb ischemia and deep venous thrombosis in Per CID group
  • 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
  • safety of remote perconditioning ischemic process [ Time Frame: 7 days ]
    Percentage of hemorrhagic transformation in case of IV thrombolysis in the 2 groups
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE REmote iSchemic Conditioning in acUtE BRAin INfarction Study
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Infarction
Intervention  ICMJE
  • 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').

  • Other: Usual care
Study Arms  ICMJE
  • Experimental: With per-CID protocol
    Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .
    Intervention: Device: Lower limb tourniquet
  • Without per-CID protocol
    Usual care patients (thrombolysis or not).
    Intervention: Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189928
Other Study ID Numbers  ICMJE P14/01_RESCUE BRAIN
2014-A00104-43 ( Registry Identifier: ID RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Pr Fernando PICO, Versailles Hospital
Study Sponsor  ICMJE Versailles Hospital
Collaborators  ICMJE Unité de Recherche Clinique Paris IDF Ouest
Investigators  ICMJE
Principal Investigator: Fernando PICO, Neurology Department head Versailles Hospital
PRS Account Versailles Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP