Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.

Detailed Description

This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.

Conditions

Interventions

  • Control group Other
    Other Names: control
    ARM 1: Kind: Experimental
    Label: Control group
    Description: RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.
  • RIPC group Device
    Other Names: Brand name: Doctormate; Type: IPC-906X; Productor: Beijing Renqiao Institute of Neuroscience
    ARM 1: Kind: Experimental
    Label: RIPC group
    Description: RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Local tissue damage 30 days after RIPC treatment 30 days after RIPC treatment Yes
Primary Levels of plasma biomarkers assay right before RIPC treatment right before RIPC treatment (within 24hrs) No
Primary Levels of plasma biomarkers assay 3 days after RIPC treatment. 3 days after RIPC treatment. No
Primary Levels of plasma biomarkers assay 15 days after RIPC treatment. 15 days after RIPC treatment. No
Primary Levels of plasma biomarkers assay 30 days after RIPC treatment 30 days after RIPC treatment No
Primary Levels of plasma biomarkers assay right after RIPC treatment right after RIPC treatment (within 24hrs) No
Secondary Infarct volume evaluation before RIPC treatment. Acute phase of ischemic stroke, and before RIPC treatment No
Secondary Infarct volume after RIPC treatment in ischemic stroke patients 30 days after RIPC treatment in ischemic stroke patients No

Sponsors