Cerebral Infarction
Conditions
Brief 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.
Interventions
DEVICELower 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').
OTHERUsual care
Sponsors
Unité de Recherche Clinique Paris IDF Ouest
Versailles Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| safety of remote perconditioning ischemic process | 7 days | \- Rate of lower limb ischemia and deep venous thrombosis in Per CID group |
Countries
France
Outcome results
None listed