International journal of stroke : official journal of the International Stroke Society
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Randomized Controlled Trial
Design and rationale of the Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE) Trial.
Multimodal imaging has the potential to identify acute ischaemic stroke patients most likely to benefit from late recanalization therapies. ⋯ The primary aim of the trial is to test the hypothesis that the presence of substantial ischaemic penumbral tissue visualized on multimodal imaging (magnetic resonance imaging or computed tomography) predicts patients most likely to respond to mechanical embolectomy for treatment of acute ischaemic stroke due to a large vessel, intracranial occlusion up to eight-hours from symptom onset. This hypothesis will be tested by analysing whether pretreatment imaging pattern has a significant interaction with treatment as a determinant of functional outcome based on the distribution of scores on the modified Rankin Scale measure of global disability assessed 90 days post-stroke. Nested hypotheses test for (1) treatment efficacy in patients with a penumbral pattern pretreatment, and (2) absence of treatment benefit (equivalency) in patients without a penumbral pattern pretreatment. An additional aim will only be tested if the primary hypothesis of an interaction is negative: that patients treated with mechanical embolectomy have improved functional outcome vs. standard medical management.
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Randomized Controlled Trial Multicenter Study
A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA).
Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 4·5 h of ischemic stroke onset. However, tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients. We hypothesized that anterior circulation ischemic stroke patients, selected with 'dual target' vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging 'mismatch' within 4·5 h of onset, would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone. ⋯ The coprimary outcome measure will be reperfusion at 24 h and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1) at day 3. Secondary outcomes include modified Rankin Scale at day 90, death, and symptomatic intracranial hemorrhage.
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Randomized Controlled Trial
Endovascular therapeutic hypothermia for acute ischemic stroke: ICTuS 2/3 protocol.
Therapeutic hypothermia improves neurological outcome after out-of-hospital cardiac arrest or neonatal hypoxic-ischemic injury. Although supported by preclinical evidence, therapeutic hypothermia for acute stroke remains under study. In the Intravascular Cooling in the Treatment of Stroke (ICTuS) trial, awake stroke patients were successfully cooled using an endovascular cooling catheter and a novel antishivering regimen. ⋯ The ICTuS 2/3 protocol contains novel features - based on the previous ICTuS and ICTuS-L trials - designed to achieve these milestones. Innovations include scrupulous pneumonia surveillance, intravenous chilled saline immediately after randomization to induce rapid cooling, and a requirement for catheter placement within two-hours of thrombolysis. An Investigational Device Exemption has been obtained and an initial group of sites initiated.
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Novel oral anticoagulants provide an effective and convenient alternative to warfarin for stroke prevention in patients with atrial fibrillation. However, novel anticoagulants also present new challenges for stroke physicians, such as measurement of anticoagulant effect in emergency situations, use of thrombolysis in acute ischemic stroke, optimal timing of introduction of novel anticoagulants following acute ischemic stroke, and management of intracerebral hemorrhage. In this review, we propose pragmatic approaches to dealing with challenging management issues that will face stroke physicians who care for patients with acute stroke in the novel oral anticoagulant era.
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Fever, hyperglycemia, and swallow dysfunction poststroke are associated with significantly worse outcomes. We report treatment and monitoring practices for these three items from a cohort of acute stroke patients prior to randomization in the Quality in Acute Stroke Care trial. ⋯ Our results showed that acute stroke patients were: undermonitored and undertreated for fever and hyperglycemia; and underscreened for swallowing dysfunction and unnecessarily reassessed by a speech pathologist, indicating the need for urgent behavior change.