REmote iSchemic Conditioning in acUtE BRAin INfarction Study
关键词
抽象
日期
| 最后验证: | 08/31/2018 |
| 首次提交: | 06/09/2014 |
| 提交的预估入学人数: | 07/10/2014 |
| 首次发布: | 07/14/2014 |
| 上次提交的更新: | 09/02/2018 |
| 最近更新发布: | 09/04/2018 |
| 实际学习开始日期: | 12/31/2014 |
| 预计主要完成日期: | 12/31/2018 |
| 预计完成日期: | 12/31/2018 |
状况或疾病
干预/治疗
Device: With per-CID protocol
Other: Without per-CID protocol
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Brain MRI changes of DWI ( Diffusion-Weighted Imaging) brain infarction volume (cc) between baseline (
次要成果指标
1. Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control) [3 months]
其他成果措施
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]
