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Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis

Primary Purpose

Vertebrobasilar Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ischemic conditioning
Sponsored by
Ji Xunming
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vertebrobasilar Ischemia focused on measuring stroke, Vertebrobasilar atherosclerosis, remote ischemic conditioning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female with age from 18 to 80 years old.
  • Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior to randomization.
  • The entry event is attributed to symptomatic atherosclerotic lesion(stenosis is greater than or equal to 50% or occlusion)in vertebrobasilar artery that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
  • Informed consent obtained.

Exclusion Criteria:

  1. Thrombolytic therapy within 24 hours prior to enrollment.
  2. Progressive neurological signs within 24 hours prior to enrollment.
  3. Cerebral venous thrombosis/stenosis.
  4. vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other infection; any artery stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
  5. Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
  6. Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication].
  7. Patients with serious complications or abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) >3×upper limit of normal range; creatinine clearance <0.6 ml/s and/or serum creatinine >265 μmol/l (>3.0 mg/dl); platelets <100×109/L.
  8. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
  9. Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
  10. Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
  11. Severe hemostatic disorder or severe coagulation dysfunction.
  12. Subclavian arterial stenosis≥50% or subclavian steal syndrome.
  13. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment.
  14. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 6 months after enrollment.
  15. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
  16. Pregnant or breast-feeding women.
  17. Unwilling to be followed up or poor compliance for treatment.
  18. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
  19. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    RIC group

    Control group

    Arm Description

    Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy.

    The participants receive a standard clinical therapy after diagnosed ischemic stroke.

    Outcomes

    Primary Outcome Measures

    number of ischemic cerebrovascular events with vertebrobasilar responsibility
    ischemic cerebrovascular events include ischemic stroke and transient ischemic attack

    Secondary Outcome Measures

    number of composite outcomes events
    composite outcomes events include Number of ischemic stroke ,transient ischemic attack ,cerebral hemorrhage and mortality
    Number of participants with adverse events that are related to treatment
    number of participants with mRS 0-1
    changes of hemodynamics
    hemodynamics evaluation by transcranial doppler
    changes of plasma biomarkers
    changes of plasma VEGF and index of thromboelastogramat at the baseline,in the first 3 and 6 months

    Full Information

    First Posted
    November 16, 2016
    Last Updated
    November 19, 2016
    Sponsor
    Ji Xunming
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02971462
    Brief Title
    Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ji Xunming

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vertebrobasilar Ischemia
    Keywords
    stroke, Vertebrobasilar atherosclerosis, remote ischemic conditioning

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RIC group
    Arm Type
    Experimental
    Arm Description
    Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The participants receive a standard clinical therapy after diagnosed ischemic stroke.
    Intervention Type
    Device
    Intervention Name(s)
    ischemic conditioning
    Other Intervention Name(s)
    Doctormate, IPC-906
    Intervention Description
    In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
    Primary Outcome Measure Information:
    Title
    number of ischemic cerebrovascular events with vertebrobasilar responsibility
    Description
    ischemic cerebrovascular events include ischemic stroke and transient ischemic attack
    Time Frame
    0-6 months from randomization
    Secondary Outcome Measure Information:
    Title
    number of composite outcomes events
    Description
    composite outcomes events include Number of ischemic stroke ,transient ischemic attack ,cerebral hemorrhage and mortality
    Time Frame
    0-6 months from randomization
    Title
    Number of participants with adverse events that are related to treatment
    Time Frame
    0-6 months from randomization
    Title
    number of participants with mRS 0-1
    Time Frame
    0-6 months from randomization
    Title
    changes of hemodynamics
    Description
    hemodynamics evaluation by transcranial doppler
    Time Frame
    0-6 months from randomization
    Title
    changes of plasma biomarkers
    Description
    changes of plasma VEGF and index of thromboelastogramat at the baseline,in the first 3 and 6 months
    Time Frame
    baseline,3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female with age from 18 to 80 years old. Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior to randomization. The entry event is attributed to symptomatic atherosclerotic lesion(stenosis is greater than or equal to 50% or occlusion)in vertebrobasilar artery that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA). Informed consent obtained. Exclusion Criteria: Thrombolytic therapy within 24 hours prior to enrollment. Progressive neurological signs within 24 hours prior to enrollment. Cerebral venous thrombosis/stenosis. vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other infection; any artery stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus. Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation. Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication]. Patients with serious complications or abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) >3×upper limit of normal range; creatinine clearance <0.6 ml/s and/or serum creatinine >265 μmol/l (>3.0 mg/dl); platelets <100×109/L. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment. Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation. Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment. Severe hemostatic disorder or severe coagulation dysfunction. Subclavian arterial stenosis≥50% or subclavian steal syndrome. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 6 months after enrollment. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs. Pregnant or breast-feeding women. Unwilling to be followed up or poor compliance for treatment. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xunming Ji, MD. PhD
    Phone
    +86-10-83198952
    Email
    jixunming@vip.163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xunming Ji, MD. PhD
    Organizational Affiliation
    Xuanwu Hospital, Beijing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis

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