Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients "IRAS"

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC) initiates autonomic nervous system response and affects the prognosis in patients with acute ischemic stroke.

Detailed Description

Remote ischemic postconditioning (RIPostC) has proven effective in reducing the ischemia-reperfusion injury. But the defensive mechanism of RIPostC still unclear. Stroke is frequently associated with autonomic dysfunction. Heart rate variability (HRV) represents the autonomic nervous system activity.This study aims to investigate whether RIPostC correlates with autonomic function and thus predicts prognosis of stroke.

Conditions

Interventions

  • Remote ischemic postconditioning Procedure
    Other Names: PIPostC
    Intervention Desc: Remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion.The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to 200 mmHg for 5 min,and then deflating it for 5 min.Each patients in the PIPostC group will have the treatment once a day for 30 days.
    ARM 1: Kind: Experimental
    Label: RIPostC
    Description: Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning
  • Sham remote ischemic postconditioning Procedure
    Other Names: sham PIPostC
    Intervention Desc: Sham remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion. The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to the patient's actual diastolic blood pressure for 5 min,and then deflating it for 5 min.Each patients in the sham PIPostC group will have the sham treatment once a day for 30 days.
    ARM 1: Kind: Experimental
    Label: sham RIPostC
    Description: Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure. Intervention:Procedure:Sham Remote Ischemic Postconditioning

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Heart Rate Variability(HRV) at the time points of baseline and 7 and 30 days after treatments Yes
Secondary National Institutes of Health Stroke Scale(NIHSS) at the time points of baseline and 7 and 30 days after treatments Yes
Secondary Modified Rankin scale(mRS) at the time points of baseline and 7,30 and 90 days after treatments Yes
Secondary Barthel Index(BI) at the time points of baseline and 7,30 and 90 days after treatments Yes
Primary Heart Rate Variabilities at the time points of baseline and 7 and 30 days after treatments

Sponsors