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Effects of Limb Ischemic Postconditioning in Young sICAS (EPIC-sICAS)

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ClinicalTrials.gov Identifier: NCT02323425
Recruitment Status : Unknown
Verified January 2017 by Meng Wei, Health Science Center of Xi'an Jiaotong University.
Recruitment status was:  Recruiting
First Posted : December 23, 2014
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Xuanwu Hospital, Beijing
Information provided by (Responsible Party):
Meng Wei, Health Science Center of Xi'an Jiaotong University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

Condition or disease Intervention/treatment Phase
Stroke Device: Remote ischemic postconditioning Not Applicable

Detailed Description:

Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis（sICAS）is a major cause, especially in Asians.

Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.

Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Remote Ischemic Postconditioning
remote ischemic postconditioning（RIPC） treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation twice a day for the total of 180 consecutive days.
 Device: Remote ischemic postconditioning
Remote ischemic postconditioning（RIPC）treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically.
Other Name: limb ischemic postconditioning
No Intervention: Control
Patients in control group will receive foundation treatment. Foundation treatment: including blood vessel expansion、free radical elimination etc during acute phase and aspirin (100-300 mg/d), and atorvastatin (20 mg/d) till the end of the study (180 consecutive days).


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change of Collateral Circulation from Baseline and at 6 months [ Time Frame: Baseline and at 6 months ]
    Collateral circulation measured in iconography test: Magnetic Resonance Angiography (MRA)、 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)、Arterial spin-labeled (ASL) perfusion magnetic resonance、Transcranial Cerebral Doppler (TCD)、single photon emission computed tomography（SPECT） Baseline was defined as the onset of stroke within 48h. A higher score represents better collateral circulation status functioning.


Secondary Outcome Measures :
  1. Mean Change of Symptomatic Recovery [ Time Frame: Baseline and at 14 days, 1 month, 6 months, and 1 year ]
    Functional test: National Institute of Health stroke scale（NIHSS）scores、Activity of Daily Living Scale (ADL) For NIHSS scores, a lower score represents better functioning. For ADL scores, a higher score represents better functioning.

  2. Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days. [ Time Frame: Baseline and at 10 days ]
    A higher amount represents a better outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 to 45 Years old;
  2. Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery;
  3. National Institutes of Health Stroke Scale(NIHSS) score 0-15
  4. Written informed consent was signed.

Exclusion Criteria:

  1. Cerebral hemorrhage and other parts of the active bleeding disease;
  2. Severe aphasia, unable to express himself;
  3. A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;
  4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;
  5. Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment;
  6. Dementia and mental illness;
  7. Using angiotensin-converting enzyme inhibitors;
  8. A history of major surgery or trauma 4 weeks prior to admission;
  9. Without informed consent.

Elimination Criteria：

  1. Patients with poor compliance，refuse to take regular treatment and examination;
  2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.
Contacts and Locations
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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): NCT02323425


Contacts
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Contact: Meng Wei, Master +8613572516964 67183723@qq.com
Contact: GuoGang Luo, M.D/Ph.D +8618991232449 lguogang@163.com

Locations
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China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Meng Wei, graduate    +8613572516964    67183723@qq.com   
Contact: GuoGang Luo, M.D/Ph.D    +8618991232449    lguogang@163.com   
Principal Investigator: GuoGang Luo, M.D/Ph.D         
Principal Investigator: XunMing Ji, M.D/Ph.D         
Sponsors and Collaborators
Health Science Center of Xi'an Jiaotong University
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: GuoGang Luo, M.D/Ph.D First Affiliated Hospital Xi'an Jiaotong University
Study Director: Xunming Ji, M.D/Ph.D Capital Medical University
More Information
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Responsible Party: Meng Wei, Director, Clinical Research, Health Science Center of Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02323425    
Other Study ID Numbers: XIANJ-14ZD25
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Meng Wei, Health Science Center of Xi'an Jiaotong University:
stroke
Remote ischemic postconditioning
symptomatic atherosclerotic intracranial arterial stenosis
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes