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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