The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease

Completed

Phase 1/2 Results

Trial Description

This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.

Conditions

Interventions

  • Remote ischemic preconditioning (RIPC) Procedure
    Intervention Desc: The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
    ARM 1: Kind: Experimental
    Label: RIPC+stroke secondary prevension
    Description: Procedure/Surgery: RIPC RIPC consisted of five 5-min cycles of one upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated. This process was placed on both arms every day. Procedure:stroke secondary prevention

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The frequency ischemic stroke or transient ischemic attack 6 months, one year Yes
Secondary the Serum biomarkers of preconditioning answer 6 months, one year Yes
Secondary the blood flow velocity changes of cerebral vessels by transcranial doppler 6 months, one year Yes
Secondary the changes of cerebral perfusion and metabolism measured by SPECT six month, one year Yes
Primary Blood Pressure and Heart Rates; at the time points of baseline and 1, 15 and 30 days after BLIPC treatment Yes
Primary Plasma Biomarkers of Coagulation and Fibrinolysis the time points of baseline and 1, 15 and 30 days after BLIPC treatment Yes
Primary Number of Patients Who Got New Brain Lesions 300 days after treatment Yes
Secondary The Time Point Until the First Stroke Recurrence, At the 300-day after the initial treatment Yes
Secondary Brain Perfusion Improvement Are Evaluated With SPECT and TCD 300-day after treatment Yes

Sponsors