REmote iSchemic Conditioning in acUtE BRAin INfarction Study (RESCUE-BRAIN)
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|ClinicalTrials.gov Identifier: NCT02189928|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2014
Last Update Posted : September 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Infarction||Device: Lower limb tourniquet Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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)|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: With per-CID protocol
Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .
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').
Without per-CID protocol
Usual care patients (thrombolysis or not).
Other: Usual care
- 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)
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189928
|Centre Hospitalier Sud Francilien|
|Corbeil-Essonne, France, 91100|
|Hôpital Henri Mondor|
|Créteil, France, 94000|
|Centre Hospitalier de Versailles|
|Le Chesnay, France, 78150|
|CHU de Nantes|
|Nantes, France, 44093|
|Paris, France, 75013|
|Fondation Ophtalmologique Adolphe de Rothschild|
|Paris, France, 75019|
|Paris, France, 78018|
|CHU de Strasbourg|
|Strasbourg, France, 67098|
|Suresnes, France, 92150|
|Principal Investigator:||Fernando PICO, Neurology Department head||Versailles Hospital|