NCT02189928

REmote iSchemic Conditioning in acUtE BRAin INfarction Study

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Versailles Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Infarction

Interventions

Type	Name	Description
DEVICE	Lower 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').
OTHER	Usual care

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2014-07-15
• Last updated: 2018-09-05

Locations

9 sites across 1 country: France