REmote iSchemic Conditioning in acUtE BRAin INfarction Study
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 08/31/2018 |
| Iliyowasilishwa Kwanza: | 06/09/2014 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 07/10/2014 |
| Iliyotumwa Kwanza: | 07/14/2014 |
| Sasisho la Mwisho Liliwasilishwa: | 09/02/2018 |
| Sasisho la Mwisho Lilichapishwa: | 09/04/2018 |
| Tarehe halisi ya kuanza kwa masomo: | 12/31/2014 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 12/31/2018 |
| Tarehe ya Kukamilisha Utafiti: | 12/31/2018 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: With per-CID protocol
Other: Without per-CID protocol
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: With per-CID protocol Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet . | Device: With per-CID protocol 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'). |
| Other: Without per-CID protocol Usual care patients (thrombolysis or not). | Other: Without per-CID protocol |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Brain MRI changes of DWI ( Diffusion-Weighted Imaging) brain infarction volume (cc) between baseline (
Hatua za Matokeo ya Sekondari
1. Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control) [3 months]
Hatua Nyingine za Matokeo
1. safety of remote perconditioning ischemic process [7 days]
2. safety of remote perconditioning ischemic process [7 days]
3. safety of remote perconditioning ischemic process [7 days]
