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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00104-43 | Registry Identifier | ID RCB |
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| Name | Class |
|---|---|
| Unité de Recherche Clinique Paris IDF Ouest | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With per-CID protocol | Experimental | Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet . |
|
| Without per-CID protocol | Other | Usual care patients (thrombolysis or not). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower limb tourniquet | 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'). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| safety of remote perconditioning ischemic process | - Rate of lower limb ischemia and deep venous thrombosis in Per CID group | 7 days |
| safety of remote perconditioning ischemic process | Rate of early neurological worsening (NIHSS score (d1- d0) > 4 points) in Per-CID and control group |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando PICO, Neurology Department head | Versailles Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonne | 91100 | France | |||
| Hôpital Henri Mondor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32227157 | Derived | 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. | |
| 27412192 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2021 | |
| Reset | Feb 18, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2021 | Feb 18, 2021 |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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|
| Usual care | Other |
|
| 7 days |
| safety of remote perconditioning ischemic process | Percentage of hemorrhagic transformation in case of IV thrombolysis in the 2 groups | 7 days |
| Créteil |
| 94000 |
| France |
| Centre Hospitalier de Versailles | Le Chesnay | 78150 | France |
| CHU de Nantes | Nantes | 44093 | France |
| Hôpital Pitie-Salpêtrière | Paris | 75013 | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| Hôpital Bichat | Paris | 78018 | France |
| CHU de Strasbourg | Strasbourg | 67098 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| Derived |
| 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. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |