title: The Design and Rationale of a Clinical Trial Evaluating Limb Postconditioning in Young Patients with Intracranial Arterial Stenosis.
abstract: OBJECTIVE
  To examine the effectiveness of bilateral arm remote ischemic postconditioning (RIPC) on the rehabilitation of nerve function and collateral circulation in patients with symptomatic intracranial atherosclerotic stenosis (sICAS).
  
  
  METHODS
  Open, controlled, prospective trial (EPIC-sICAS trial) in Xi'an, Shaanxi, China.
  
  
  METHODS
  Up to 100 sICAS patients (age: 18-45 years, gender balance) who fulfill the inclusion and exclusion criteria will be enrolled and randomized to intervention group and control group (n ~ 50/group).
  
  
  METHODS
  The intervention group will undergo ischemia and reperfusion on both arms twice a day for 6 months.
  
  
  METHODS
  Mean changes in collateral circulation from baseline to the end of the 6-month RIPC treatment period, measured by dynamic contrast-enhanced magnetic resonance imaging, will be the primary outcome. Clinical symptoms, serum levels of vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF) will be compared as secondary outcome.
  
  
  RESULTS
  A safety evaluation and preliminary experiment of the EPIC-sICAS trial were completed in November 2014 and March 2015, respectively. Overall and regional brain hemodynamics remained stable throughout RIPC. Activities of daily living score and serum VEGF and bFGF levels were significantly higher (P < .05) in the intervention group.
  
  
  CONCLUSIONS
  Repetitive bilateral arm RIPC appears to have protective effects in the brain related to angiogenesis promotion and neuroprotection in the acute phase of sICAS. Assessment of the role of RIPC in collateral circulation requires imaging tests and longer follow-up, as planned in the EPIC-sICAS trial.
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Meng
authors.initials: M
authors.lastname: Wei
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Kang
authors.initials: K
authors.lastname: Huo
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Liu
authors.affiliation: Department of Medical Imaging, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Yawen
authors.initials: Y
authors.lastname: Cheng
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Sha
authors.initials: S
authors.lastname: Chang
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
authors.forename: Danfeng
authors.initials: D
authors.lastname: Ren
authors.affiliation: Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China. Electronic address: lguogang@163.com.
authors.forename: Guogang
authors.initials: G
authors.lastname: Luo
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001157:Arterial Occlusive Diseases / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D015415:Biomarkers / Q000097:blood; D002681:China; D002985:Clinical Protocols; D003097:Collateral Circulation; D003287:Contrast Media; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000097:blood; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D057775:Ischemic Postconditioning / Q000009:adverse effects / Q000379:methods*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D018919:Neovascularization, Physiologic; D011446:Prospective Studies; D020127:Recovery of Function; D012039:Regional Blood Flow; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D034941:Upper Extremity / Q000098:blood supply*; D042461:Vascular Endothelial Growth Factor A / Q000097:blood; D055815:Young Adult
chemical_list: D015415:Biomarkers; D003287:Contrast Media; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D016222:Fibroblast Growth Factor 2
keywords: Upper limb ischemic postconditioning; basic fibroblast growth factor; symptomatic intracranial atherosclerotic stenosis; vascular endothelial growth factor