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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
With per-CID protocol
Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .
干预措施: Lower limb tourniquet (Device)
Without per-CID protocol
Usual care patients (thrombolysis or not).
干预措施: Usual care (Other)
结局指标
主要结局
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)
时间窗: 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)
次要结局
- Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control)(3 months)
研究者
Pr Fernando PICO
Investigator coordinator
Versailles Hospital