Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory
      effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the
      investigators will use clinical outcome, serum biochemical markers and brain magnetic
      resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory
      effects on patients undergoing carotid artery stenting.
    

Detailed description: 
      BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in
      Carotid Artery Stenting. Remote ischemic preconditioning (RIPC), brief periods of ischemia
      followed by reperfusion, can provide systemic protection for prolonged ischemia. Our previous
      study found no significant protection to the patients who received once RIPC before Carotid
      Artery Stenting. In order to investigate whether long-term RIPC before Carotid Artery
      Stenting can protect these patients from the perioperative and long-term complications, a
      prospective randomized controlled trial will be performed in the current study.

      DESIGNING: About 189 patients who are eligible for carotid artery stenting will be randomly
      assigned in 1:1:1 ratio to RIPC group, sham RIPC group and conventional Carotid Artery
      Stenting group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five
      5-min cycles of bilateral arm ischemia/reperfusion, it is induced by an automated
      cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by
      deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least
      two weeks before carotid artery stenting. Patients in the sham RIPC group receive sham RIPC
      treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion,
      induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for
      5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least two
      weeks before carotid artery stenting. Patients in the control group receive conventional
      carotid artery stenting without RIPC or sham RIPC treatment. Cerebral injury is assessed by
      serum S-100B and Neuron specific enolase (NSE), systematic inflammation is assessed by serum
      high-sensitivity C-reactive protein (hs-CRP). Post-treatment infarctions, both symptomatic
      and asymptomatic, are detected by diffusion-weighted imaging (DWI) and clinical outcomes are
      determined by cerebrovascular events, cardiac events or death.
    

Intervention name(s): Remote ischemic preconditioning; Sham remote ischemic preconditioning; Carotid Artery Stenting
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.; Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.; Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
Other intervention name(s): RIPC; Sham RIPC; CAS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Remote ischemic preconditioning; Stroke secondary prevention; Carotid artery stenting; Carotid stenosis; Inflammation