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Randomized Controlled Trial
Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial.
- Kristina Dupont Hougaard, Niels Hjort, Dora Zeidler, Leif Sørensen, Anne Nørgaard, Troels Martin Hansen, Paul von Weitzel-Mudersbach, Claus Z Simonsen, Dorte Damgaard, Hanne Gottrup, Kristina Svendsen, Peter Vestergaard Rasmussen, Lars R Ribe, Irene K Mikkelsen, Kartheban Nagenthiraja, Tae-Hee Cho, Andrew N Redington, Hans Erik Bøtker, Leif Østergaard, Kim Mouridsen, and Grethe Andersen.
- From the Department of Neurology (K.D.H., N.H., P.v.W.-M., C.Z.S., D.D., H.G., K.S., P.V.R., G.A.), Department of Neuroradiology (L.S., A.N., L.Ø.), Department of Cardiology (H.E.B.), and Mobil Emergency Care Unit Aarhus (T.M.H.), Aarhus University Hospital, Aarhus, Denmark; Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark (K.D.H., N.H., D.Z., L.R.R., I.K.M., K.N., L.Ø., K.M.); Stroke Department, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, University of Lyon, Lyon, France (T.-H.C.); and Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada (A.N.R.).
- Stroke. 2014 Jan 1;45(1):159-67.
Background And PurposeRemote ischemic preconditioning is neuroprotective in models of acute cerebral ischemia. We tested the effect of prehospital rPerC as an adjunct to treatment with intravenous alteplase in patients with acute ischemic stroke.MethodsOpen-label blinded outcome proof-of-concept study of prehospital, paramedic-administered rPerC at a 1:1 ratio in consecutive patients with suspected acute stroke. After neurological examination and MRI, patients with verified stroke receiving alteplase treatment were included and received MRI at 24 hours and 1 month and clinical re-examination after 3 months. The primary end point was penumbral salvage, defined as the volume of the perfusion-diffusion mismatch not progressing to infarction after 1 month.ResultsFour hundred forty-three patients were randomized after provisional consent, 247 received rPerC and 196 received standard treatment. Patients with a nonstroke diagnosis (n=105) were excluded from further examinations. The remaining patients had transient ischemic attack (n=58), acute ischemic stroke (n=240), or hemorrhagic stroke (n=37). Transient ischemic attack was more frequent (P=0.006), and National Institutes of Health Stroke Scale score on admission was lower (P=0.016) in the intervention group compared with controls. Penumbral salvage, final infarct size at 1 month, infarct growth between baseline and 1 month, and clinical outcome after 3 months did not differ among groups. After adjustment for baseline perfusion and diffusion lesion severity, voxelwise analysis showed that rPerC reduced tissue risk of infarction (P=0.0003).ConclusionsAlthough the overall results were neutral, a tissue survival analysis suggests that prehospital rPerC may have immediate neuroprotective effects. Future clinical trials should take such immediate effects, and their duration, into account.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00975962.
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