title: CHIMES-I: sub-group analyzes of the effects of NeuroAiD according to baseline brain imaging characteristics among patients randomized in the CHIMES study.
abstract: BACKGROUND
  The clinical effects of neuroprotective and/or neurorestorative therapies may vary according to location and size of the ischemic injury. Imaging techniques can be useful in stratifying patients for trials that may be beneficial against particular ischemic lesion characteristics.
  
  
  OBJECTIVE
  To test the hypothesis that the efficacy of NeuroAiD compared with placebo in improving functional outcome and reducing neurological deficit in patients with cerebral infarction of intermediate severity varies between sub-groups of patients randomized in the main Chinese Medicine Neuroaid Efficacy on Stroke study when categorized according to baseline imaging characteristics.
  
  
  METHODS
  This is a retrospective cohort sub-group analysis of patients who participated in the main Chinese Medicine Neuroaid Efficacy on Stroke study, a multicenter, double-blind, placebo-controlled trial that recruited 1100 patients within 72 h of ischemic stroke onset with National Institutes of Health Stroke Scale 6-14 and were randomized to either NeuroAiD or placebo taken four capsules three times daily for three months. Review of the baseline images to classify the acute stroke lesions in terms of size, location, and extent of involvement will be performed retrospectively by two readers who will remain blinded as to treatment allocation and outcomes of the subjects.
  
  
  RESULTS
  The primary efficacy end-point in the main Chinese Medicine Neuroaid Efficacy on Stroke study is the modified Rankin Scale grades at three-months. Secondary efficacy end-points are the National Institutes of Health Stroke Scale score at three-months; difference of National Institutes of Health Stroke Scale scores between baseline and 10 days and between baseline and three-months; difference of National Institutes of Health Stroke Scale sub-scores between baseline and 10 days and between baseline and three-months; modified Rankin Scale at 10 days, one-month, and three-months; Barthel index at three-months; and Mini Mental State Examination at 10 days and three-months. Analysis of these primary and secondary end-points will be performed for sub-groups defined in this study after review of the baseline brain imaging: nonlacunar and lacunar, cortical and sub-cortical, hemispheric vs. brainstem, Alberta Stroke Program Early CT score <7 and 7-10, and score <8 and 8-10.
authors.affiliation: University of Santo Tomas Hospital, Manila, Philippines. josecnavarromd@gmail.com
authors.forename: Jose C
authors.initials: JC
authors.lastname: Navarro
authors.forename: Christopher Li Hsian
authors.initials: CL
authors.lastname: Chen
authors.forename: Pedro Danilo J
authors.initials: PD
authors.lastname: Lagamayo
authors.forename: Melodia B
authors.initials: MB
authors.lastname: Geslani
authors.forename: Gaik Bee
authors.initials: GB
authors.lastname: Eow
authors.forename: Niphon
authors.initials: N
authors.lastname: Poungvarin
authors.forename: Asita
authors.initials: A
authors.lastname: de Silva
authors.forename: Lawrence K S
authors.initials: LK
authors.lastname: Wong
authors.forename: N
authors.initials: N
authors.lastname: Venketasubramanian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059906:Neuroimaging; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D020127:Recovery of Function / Q000187:drug effects; D012107:Research Design; D020521:Stroke / Q000188:drug therapy* / Q000473:pathology*; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C546417:Neuroaid; D018696:Neuroprotective Agents
keywords: cerebral infarction; imaging; ischemic stroke; stroke; therapy; treatment