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

Versailles Hospital

Status: Unknown

Conditions: Cerebral Infarction

Treatments: Device: Lower limb tourniquet; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02189928

P14/01_RESCUE BRAIN

2014-A00104-43 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

With per-CID protocol

Experimental group

Description:

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

Treatment:

Device: Lower limb tourniquet

Without per-CID protocol

Other group

Description:

Usual care patients (thrombolysis or not).

Treatment:

Other: Usual care