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Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning

Primary Purpose

Cerebral Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doctormate®+Medical Management
Medical Management
Sponsored by
Ji Xunming,MD,PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Atherosclerosis focused on measuring cerebral atherosclerotic occlusion, remote ischemic conditioning, ischemic stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female with age from 40 to 80 years old.
  2. Patients with cerebral arterial occlusion which have been confirmed by CTA, MRA, or other evidence (including intracranial and extracranial arterial occlusion), and there is no indication of intervention and surgery, and at the same time the patients combined more than two risk factors for atherosclerosis.
  3. The entry event is acute ischemic cerebrovascular disease (TIA or cerebral infarction), of which the condition was relatively stable within 30 days of onset, and mRS≤4.
  4. 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. Intracranial arterial occlusion due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial 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 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. Extracranial stenosis ≥50%.
  14. 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.
  15. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 12 months after enrollment.
  16. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
  17. Life expectancy<3 years.
  18. Pregnant or breast-feeding women.
  19. Unwilling to be followed up or poor compliance for treatment.
  20. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
  21. 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

    Other

    Arm Label

    Experiment

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    3-month composite cardio-cerebral vascular event rate

    Secondary Outcome Measures

    Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
    Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
    Changes in modified Rankin Scale(mRS) within 3 months
    Changes in Barthel Index(BI) within 3 months
    12-month composite cardio-cerebral vascular event rate

    Full Information

    First Posted
    July 6, 2020
    Last Updated
    July 9, 2020
    Sponsor
    Ji Xunming,MD,PhD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04470492
    Brief Title
    Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning
    Official Title
    Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    August 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) together with conventional medication therapy compared with only medication therapy reduces the 3-month risk of composite cardio-cerebral vascular event in patients with a recent TIA or IS caused by occlusion of a cerebral artery. After screening period, eligible patients will be randomly allocated into 2 groups.In addition, all participants receive an usual clinical therapy.
    Detailed Description
    In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication; patients in the control group will be treated only with conventional medication. In the study, the RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Atherosclerosis
    Keywords
    cerebral atherosclerotic occlusion, remote ischemic conditioning, ischemic stroke

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    700 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experiment
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    Other
    Intervention Type
    Combination Product
    Intervention Name(s)
    Doctormate®+Medical Management
    Intervention Description
    Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Medical Management
    Intervention Description
    Patients will be treated with conventional medication for 3 months.
    Primary Outcome Measure Information:
    Title
    3-month composite cardio-cerebral vascular event rate
    Time Frame
    During the first 3 months from randomization.
    Secondary Outcome Measure Information:
    Title
    Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
    Time Frame
    During the first 3 months from randomization.
    Title
    Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
    Time Frame
    During the first 3 months from randomization.
    Title
    Changes in modified Rankin Scale(mRS) within 3 months
    Time Frame
    During the first 3 months from randomization.
    Title
    Changes in Barthel Index(BI) within 3 months
    Time Frame
    During the first 3 months from randomization.
    Title
    12-month composite cardio-cerebral vascular event rate
    Time Frame
    During the first 12 months from randomization.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female with age from 40 to 80 years old. Patients with cerebral arterial occlusion which have been confirmed by CTA, MRA, or other evidence (including intracranial and extracranial arterial occlusion), and there is no indication of intervention and surgery, and at the same time the patients combined more than two risk factors for atherosclerosis. The entry event is acute ischemic cerebrovascular disease (TIA or cerebral infarction), of which the condition was relatively stable within 30 days of onset, and mRS≤4. 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. Intracranial arterial occlusion due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial 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 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. Extracranial stenosis ≥50%. 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 12 months after enrollment. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs. Life expectancy<3 years. 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

    Plan to Share IPD
    Undecided

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    Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning

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