The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting

Recruiting

Phase 1 Results N/A

Trial Description

Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging (DW-MRI)to determine the extent of its neuro-protective and anti-inflammatory effect.

Detailed Description

BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective Carotid Artery Stenting, a randomized trial will be performed in current study.
DESIGNING 60 patients will be randomized to Carotid Artery Stenting with RIPC group or conventional Carotid Artery Stenting group (control). RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins. Cerebral injury was assessed by S-100b, NSE, hs-CRP and MMSE test in different time points.

Conditions

Interventions

  • Carotid Artery Stenting Device
    Intervention Desc: Carotid Artery Stenting is an invasive therapy of carotid stenosis.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Device: RIPC RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins Procedure: Carotid Artery Stenting
    ARM 2: Kind: Experimental
    Label: 2
    Description: Procedure: Carotid Artery Stenting
  • Remote limb ischemic preconditioning Procedure
    Other Names: RIPC
    Intervention Desc: Remote limb ischemic preconditioning consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins
    ARM 1: Kind: Experimental
    Label: 1
    Description: Device: RIPC RIPC consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins Procedure: Carotid Artery Stenting

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Caregiver)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary cognitive disorder assessment 2 days Yes
Primary serum biomarkers 2 days Yes
Primary new brain lesions 2DAYS Yes
Secondary composite endpoint of any stroke,MI,or death 3months Yes

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