Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Overview

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.

Full Title of Study: “Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2013

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.

Interventions

  • Device: RIPC group
  • Device: Control group

Arms, Groups and Cohorts

  • Experimental: RIPC group
    • 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.
  • Sham Comparator: Control group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Local tissue damage 30 days after RIPC treatment
    • Time Frame: 30 days after RIPC treatment
    • Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
  • Levels of plasma biomarkers assay right before RIPC treatment
    • Time Frame: right before RIPC treatment (within 24hrs)
    • levels of CRP、TINF-α、slCAM-1 and GFAP
  • Levels of plasma biomarkers assay 3 days after RIPC treatment.
    • Time Frame: 3 days after RIPC treatment.
    • levels of CRP、TINF-α、slCAM-1 and GFAP
  • Levels of plasma biomarkers assay 15 days after RIPC treatment.
    • Time Frame: 15 days after RIPC treatment.
    • levels of CRP、TINF-α、slCAM-1 and GFAP
  • Levels of plasma biomarkers assay 30 days after RIPC treatment
    • Time Frame: 30 days after RIPC treatment
    • levels of CRP、TINF-α、slCAM-1 and GFAP
  • Levels of plasma biomarkers assay right after RIPC treatment
    • Time Frame: right after RIPC treatment (within 24hrs)
    • levels of CRP、TINF-α、slCAM-1 and GFAP

Secondary Measures

  • Infarct volume evaluation before RIPC treatment.
    • Time Frame: Acute phase of ischemic stroke, and before RIPC treatment
    • MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.
  • Infarct volume after RIPC treatment in ischemic stroke patients
    • Time Frame: 30 days after RIPC treatment in ischemic stroke patients
    • Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment

Participating in This Clinical Trial

Inclusion Criteria

1. age between 40 to 80 Years 2. Ischemic cerebrovascular disease within 6 hours 3. National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4 4. Cranial CT to rule out the the cerebral hemorrhage 5. Written informed consent was Exclusion Criteria:

1. Cerebral hemorrhage 2. Other parts of the active bleeding disease 3. Atrial fibrillation 4. Moyamoya disease or vasculitis 5. Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy 6. Out coagulation disorder 7. Severe lesions of severe liver and kidney disease, malignancy or other systemic 8. Cannot tolerate BLIPC or without informed consent

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Capital Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ji Xunming, Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University – Capital Medical University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.