Remote Ischaemic Conditioning after Stroke Trial (RECAST): a pilot randomised placebo controlled phase II trial in acute ischaemic stroke (ISRCTN 86672015)

England, Timothy J., Hedstrom, Amanda, O’Sullivan, Saoirse, Donnelly, Richard, Barrett, David A., Sarmad, Sarir, Sprigg, Nikola and Bath, Philip M. (2017) Remote Ischaemic Conditioning after Stroke Trial (RECAST): a pilot randomised placebo controlled phase II trial in acute ischaemic stroke (ISRCTN 86672015). Stroke: a Journal of Cerebral Circulation, 48 (5). pp. 1412-1415. ISSN 0039-2499

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Abstract

Background and purpose: Repeated episodes of limb ischemia and reperfusion (remote ischemic conditioning [RIC]) may improve outcome after acute stroke. Methods: We performed a pilot blinded placebo-controlled trial in patients with acute ischemic stroke, randomized 1:1 to receive 4 cycles of RIC within 24 hours of ictus. The primary outcome was tolerability and feasibility. Secondary outcomes included safety, clinical efficacy (day 90), putative biomarkers (pre- and post-intervention, day 4), and exploratory hemodynamic measures. Results: Twenty-six patients (13 RIC and 13 sham) were recruited 15.8 hours (SD 6.2) post-onset, age 76.2 years (SD 10.5), blood pressure 159/83 mm Hg (SD 25/11), and National Institutes of Health Stroke Scale (NIHSS) score 5 (interquartile range, 3.75-9.25). RIC was well tolerated with 49 out of 52 cycles completed in full. Three patients experienced vascular events in the sham group: 2 ischemic strokes and 2 myocardial infarcts versus none in the RIC group (P=0.076, log-rank test). Compared with sham, there was a significant decrease in day 90 NIHSS score in the RIC group, median NIHSS score 1 (interquartile range, 0.5-5) versus 3 (interquartile range, 2-9.5; P=0.04); RIC augmented plasma HSP27 (heat shock protein 27; P<0.05, repeated 2-way ANOVA) and phosphorylated HSP27 (P<0.001) but not plasma S100-β, matrix metalloproteinase-9, endocannabinoids, or arterial compliance. Conclusions: RIC after acute stroke is well tolerated and appears safe and feasible. RIC may improve neurological outcome, and protective mechanisms may be mediated through HSP27. A larger trial is warranted. Clinical trial registration: URL: http://www.isrctn.com. Unique identifier: ISRCTN86672015.

Keywords:stroke, post-conditioning, biomarker
Subjects:C Biological Sciences > C741 Medical Biochemistry
Divisions:College of Science > School of Chemistry
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ID Code:31309
Deposited On:14 Mar 2018 16:53

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