Effects of Limb Ischemic Postconditioning in Young sICAS "EPIC-sICAS"

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

Detailed Description

Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis(sICAS)is a major cause, especially in Asians.
Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.
Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.

Conditions

Interventions

  • Human Urinary Kallidinogenase Drug
    Other Names: HUK
    Intervention Desc: Human urinary kallikrein, a sort of tissue kininogenase, was extracted from healthy masculine urine.Approved by the state as H20052065
    ARM 1: Kind: Experimental
    Label: Human Urinary Kallidinogenase
    Description: human urinary kallidinogenase(HUK) treatment was prescribed with intravenous infusion (0.15 PNA Unit/d, dissolved in 100ml saline) for 14 days.
    ARM 2: Kind: Experimental
    Label: RIPC in combined with HUK
    Description: remote ischemic postconditioning treatment in combined with human urinary kallidinogenase treatment were prescribed as mentioned above
  • Remote ischemic postconditioning Procedure
    Other Names: PIPostC
    Intervention Desc: Remote ischemic postconditioning(RIPC)treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically.
    ARM 1: Kind: Experimental
    Label: Remote Ischemic Postconditioning
    Description: remote ischemic postconditioning(RIPC) treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation twice a day for the total of 10 consecutive days.
    ARM 2: Kind: Experimental
    Label: RIPC in combined with HUK
    Description: remote ischemic postconditioning treatment in combined with human urinary kallidinogenase treatment were prescribed as mentioned above

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Mean Change of Collateral Circulation from Baseline and at 3 months Baseline and at 3 months Yes
Secondary Mean Change of Symptomatic Recovery Baseline and at 14 days, 1 month, 3 months, and 1 year Yes
Secondary Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 14 days. Baseline and at 14 days Yes
Primary Mean Change of Collateral Circulation from Baseline and at 6 months Baseline and at 6 months Yes
Secondary Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days. Baseline and at 10 days Yes

Sponsors