Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Capital Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01672515
First received: August 19, 2012
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Stroke
Device: RIPC group
Device: Control group
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Local tissue damage 30 days after RIPC treatment [ Time Frame: 30 days after RIPC treatment ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    levels of CRP、TINF-α、slCAM-1 and GFAP


Secondary Outcome Measures:
  • Infarct volume evaluation before RIPC treatment. [ Time Frame: Acute phase of ischemic stroke, and before RIPC treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment


Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: RIPC group
Other Names:
  • Brand name: Doctormate
  • Type: IPC-906X
  • Productor: Beijing Renqiao Institute of Neuroscience
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.
Device: Control group
Other Names:
  • Brand name: Doctormate
  • Type: modified version of IPC-906X
  • Productor: Beijing Renqiao Institute of Neuroscience

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ji Xunming, Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier: NCT01672515     History of Changes
Other Study ID Numbers: 2012-RIPC-cerebral infarction
Study First Received: August 19, 2012
Last Updated: August 22, 2012
Health Authority: China: Beijing Municipal Science and Technology Commission

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Stroke
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014