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
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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The first Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial (INTERACT1) study found that early intensive BP lowering seemed to attenuate haematoma growth when compared with a more conservative guideline based policy. Clinicians were therefore waiting with anticipation for the results of INTERACT2, in which 2839 patients with spontaneous ICH and a systolic BP between 150 and 220 mmHg were randomly assigned to receive intensive anti-hypertensive therapy with a systolic target of <140 mmHg within one hour, or a standard guideline recommended treatment of <180 mmHg. INTERACT2 failed to show a significant reduction in the rate of the primary outcome of death or major disability [modified Rankin scale score (mRS) of 3-6], with early intensive BP lowering. ⋯ Reassuringly, there were no differences in the rate of death or numbers of serious adverse events between the two groups. INTERACT2 has shown that a strategy of early and aggressive BP lowering is safe in a wide range of clinical settings, and is probably effective. The Antihypertensive Treatment of Acute Cerebral Haemorrhage (ATACH) II trial, which is using similar BP targets to INTERACT, should shed further light on the benefit of early aggressive BP lowering in patients with spontaneous ICH.
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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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In many countries, stroke is a lower priority than other diseases despite its public health impact. One issue is a lack of readily accessible comparative data to help make the case for the development of national stroke strategies. To assist in this process, we need to have a common repository of the latest published information on the impact of stroke worldwide. ⋯ In many regions data were very old or nonexistent. Such country-level data are important for citizens, clinicians, and policy makers so that local and global strategies to reduce the overall burden of stroke can be implemented. Through this first annual review of country-specific stroke epidemiology, we hope to promote discussion and provide insights into the worldwide burden of stroke.