REmote iSchemic Conditioning in acUtE BRAin INfarction Study

Cerebral Infarction Clinical Trial

— RESCUE-BRAIN  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02189928
• Other study ID #: P14/01_RESCUE BRAIN
• Secondary ID: 2014-A00104-43
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 2019

Study information

• Verified date: September 2018
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonne
France	Hôpital Henri Mondor	Créteil
France	Centre Hospitalier de Versailles	Le Chesnay
France	CHU de Nantes	Nantes
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital Bichat	Paris
France	Hôpital Pitie-Salpêtrière	Paris
France	CHU de Strasbourg	Strasbourg
France	Hôpital Foch	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Versailles Hospital	Unité de Recherche Clinique Paris IDF Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety of remote perconditioning ischemic process	- Rate of lower limb ischemia and deep venous thrombosis in Per CID group	7 days
Other	safety of remote perconditioning ischemic process	Rate of early neurological worsening (NIHSS score (d1- d0) > 4 points) in Per-CID and control group	7 days
Other	safety of remote perconditioning ischemic process	Percentage of hemorrhagic transformation in case of IV thrombolysis in the 2 groups	7 days
Primary	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	Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control)	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)	3 months