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Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RIPC group
Control group
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    RIPC group

    Control group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Local tissue damage 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
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Levels of plasma biomarkers assay 3 days after RIPC treatment.
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Levels of plasma biomarkers assay 15 days after RIPC treatment.
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Levels of plasma biomarkers assay 30 days after RIPC treatment
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Levels of plasma biomarkers assay right after RIPC treatment
    levels of CRP、TINF-α、slCAM-1 and GFAP

    Secondary Outcome Measures

    Infarct volume evaluation before RIPC treatment.
    MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.
    Infarct volume after RIPC treatment in ischemic stroke patients
    Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment

    Full Information

    First Posted
    August 19, 2012
    Last Updated
    August 22, 2012
    Sponsor
    Capital Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01672515
    Brief Title
    Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
    Official Title
    Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    October 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Capital Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RIPC group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    RIPC group
    Other Intervention Name(s)
    Brand name: Doctormate, Type: IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience
    Intervention Type
    Device
    Intervention Name(s)
    Control group
    Other Intervention Name(s)
    Brand name: Doctormate, Type: modified version of IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience
    Primary Outcome Measure Information:
    Title
    Local tissue damage 30 days after RIPC treatment
    Description
    Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
    Time Frame
    30 days after RIPC treatment
    Title
    Levels of plasma biomarkers assay right before RIPC treatment
    Description
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Time Frame
    right before RIPC treatment (within 24hrs)
    Title
    Levels of plasma biomarkers assay 3 days after RIPC treatment.
    Description
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Time Frame
    3 days after RIPC treatment.
    Title
    Levels of plasma biomarkers assay 15 days after RIPC treatment.
    Description
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Time Frame
    15 days after RIPC treatment.
    Title
    Levels of plasma biomarkers assay 30 days after RIPC treatment
    Description
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Time Frame
    30 days after RIPC treatment
    Title
    Levels of plasma biomarkers assay right after RIPC treatment
    Description
    levels of CRP、TINF-α、slCAM-1 and GFAP
    Time Frame
    right after RIPC treatment (within 24hrs)
    Secondary Outcome Measure Information:
    Title
    Infarct volume evaluation before RIPC treatment.
    Description
    MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.
    Time Frame
    Acute phase of ischemic stroke, and before RIPC treatment
    Title
    Infarct volume after RIPC treatment in ischemic stroke patients
    Description
    Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment
    Time Frame
    30 days after RIPC treatment in ischemic stroke patients

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age between 40 to 80 Years Ischemic cerebrovascular disease within 6 hours National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4 Cranial CT to rule out the the cerebral hemorrhage Written informed consent was Exclusion Criteria: Cerebral hemorrhage Other parts of the active bleeding disease Atrial fibrillation Moyamoya disease or vasculitis Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy Out coagulation disorder Severe lesions of severe liver and kidney disease, malignancy or other systemic Cannot tolerate BLIPC or without informed consent

    12. IPD Sharing Statement

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    Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

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