REmote iSchemic Conditioning in acUtE BRAin INfarction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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With per-CID protocol

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

Group Type EXPERIMENTAL

Lower limb tourniquet

Intervention Type DEVICE

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).

Group Type OTHER

Usual care

Intervention Type OTHER

Interventions

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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').

Intervention Type DEVICE

Usual care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No