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Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02534545
Recruitment Status : Unknown
Verified May 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : August 27, 2015
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Brief Summary:

The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial artery.

After screening period, eligible patients will be randomly allocated into 2 groups. In addition, all participants receive an usual clinical therapy.


Condition or disease Intervention/treatment Phase
Intracranial Atherosclerosis Device: Doctormate® (200mmHg) Device: Doctormate® (60mmHg) Not Applicable

Detailed Description:
In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months; patients in the sham RLIC group will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months. 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. Sham RLIC treatment will be conducted using the same procedure but with a minimal inflation pressure of 60mmHg, which does not result in upper limb ischemia. In addition, all participants will have received their usual drug therapy according to local medical practice.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remote Ischemic Conditioning for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerotic Stenosis
Actual Study Start Date : October 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Doctormate® (200mmHg)
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months
Device: Doctormate® (200mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.

Sham Comparator: Doctormate® (60mmHg)
Patients will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months
Device: Doctormate® (60mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.




Primary Outcome Measures :
  1. The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke. [ Time Frame: During the first 12 months from randomization. ]

Secondary Outcome Measures :
  1. The time from randomization to the first occurrence of a composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and transient ischemic attack (TIA) . [ Time Frame: During the first 12 months from randomization. ]
  2. The time from randomization to the first occurrence of each component of the composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and TIA. [ Time Frame: During the first 12 months from randomization. ]
  3. Time to death from all causes from randomization. [ Time Frame: During the first 12 months from randomization. ]

Other Outcome Measures:
  1. Scores assessed by National Institutes of Health Stroke Scale(NIHSS) [ Time Frame: During the first 12 months from randomization. ]
  2. Scores assessed by modified Rankin Scale(mRS) [ Time Frame: During the first 12 months from randomization. ]
  3. Scores assessed by Barthel Index(BI). [ Time Frame: During the first 12 months from randomization. ]
  4. Number of participants with abnormal laboratory values [ Time Frame: 3 years ]
  5. Number of participants with adverse events that are related to treatment [ Time Frame: 3 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female with age from 40 to 80 years old.
  2. Patients having an ischemic stroke or a TIA prior to randomization.

    • Patient having an ischemic stroke within 30 days with mRS score≤4 at baseline.
    • Patient having a TIA within 15 days with Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline.
  3. The entry event is attributed to symptomatic atherosclerotic stenosis (50-99%) in an intracranial qualifying artery (carotid artery, middle cerebral artery (M1), vertebral artery, or basilar artery) that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
  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 stenosis 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534545


Contacts
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Contact: Xunming Ji, MD. PhD +86-10-83198952 jixunming@vip.163.com

Locations
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Sponsors and Collaborators
Ji Xunming,MD,PhD
Investigators
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Principal Investigator: Xunming Ji, MD. PhD Xuanwu Hospital, Beijing
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Responsible Party: Ji Xunming,MD,PhD, VP, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02534545    
Other Study ID Numbers: RICA
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ji Xunming,MD,PhD, Capital Medical University:
Intracranial atherosclerotic stenosis
ischemia
remote ischemic conditioning
stroke
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Atherosclerosis
Constriction, Pathologic
Recurrence
Pathologic Processes
Pathological Conditions, Anatomical
Disease Attributes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases