NCT02189928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

June 10, 2014

Last Update Submit

September 3, 2018

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (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)

    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)

    24 hours

Secondary Outcomes (1)

  • Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control)

    3 months

Other Outcomes (3)

  • safety of remote perconditioning ischemic process

    7 days

  • safety of remote perconditioning ischemic process

    7 days

  • safety of remote perconditioning ischemic process

    7 days

Study Arms (2)

With per-CID protocol

EXPERIMENTAL

Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .

Device: Lower limb tourniquet

Without per-CID protocol

OTHER

Usual care patients (thrombolysis or not).

Other: Usual care

Interventions

Lower limb tourniquetDEVICE

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').

With per-CID protocol
Usual careOTHER
Without per-CID protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years
  • Carotid ischemic stroke
  • NIHSS score between 5 and 25
  • Brain MRI performed within 6 hours from symptoms onset
  • Affiliated with a Medicare (or rightful beneficiary)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier Sud Francilien

Corbeil-Essonne, 91100, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Pitie-Salpêtrière

Paris, 75013, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Hôpital Bichat

Paris, 78018, France

Location

CHU de Strasbourg

Strasbourg, 67098, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (2)

  • 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.

    PMID: 32227157DERIVED

  • 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.

    PMID: 27412192DERIVED

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Fernando PICO, Neurology Department head

    Versailles Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator coordinator

Study Record Dates

First Submitted

June 10, 2014

First Posted

July 15, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

FR(9)