International journal of stroke : official journal of the International Stroke Society
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Randomized Controlled Trial
Remote ischemic perconditioning in thrombolysed stroke patients: randomized study of activating endogenous neuroprotection - design and MRI measurements.
Intravenous administration of alteplase is the only approved treatment for acute ischemic stroke. Despite the effectiveness of this treatment, 50% of patients suffer chronic neurological disability, which may in part be caused by ischemia-reperfusion injury. Remote ischemic perconditioning, performed as a transient ischemic stimulus by blood-pressure cuff inflation to an extremity, has proven effective in attenuating ischemia-reperfusion injury in animal models of stroke. Remote ischemic perconditioning increases myocardial salvage in patients undergoing acute revascularization for acute myocardial infarction. To clarify whether a similar benefit can be obtained in patients undergoing thrombolysis for acute stroke, we included patients from June 2009 to January 2011. ⋯ This phase 3 trial is the first study in patients with acute ischemic stroke to evaluate the effect size of remote ischemic perconditioning as a pretreatment to intravenous alteplase, measured as penumbral salvage on multimodal magnetic resonance imaging and clinical outcome after three-months follow-up.
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Randomized Controlled Trial Multicenter Study
Sleep-disordered breathing in acute ischemic stroke and transient ischemic attack: effects on short- and long-term outcome and efficacy of treatment with continuous positive airways pressure--rationale and design of the SAS CARE study.
Sleep-disordered breathing represents a risk factor for cardiovascular morbidity and mortality and negatively affects short-term and long-term outcome after an ischemic stroke or transient ischemic attack. The effect of continuous positive airways pressure in patients with sleep-disordered breathing and acute cerebrovascular event is poorly known. The SAS CARE 1 study assesses the effects of sleep-disordered breathing on clinical evolution, vascular functions, and markers within the first three-months after an acute cerebrovascular event. The SAS CARE 2 assesses the effect of continuous positive airways pressure on clinical evolution, cardiovascular events, and mortality as well as vascular functions and markers at 12 and 24 months after acute cerebrovascular event. ⋯ The SAS CARE study will improve our understanding of the clinical sleep-disordered breathing in patients with acute cerebrovascular event and the feasibility/efficacy of continuous positive airways pressure treatment in selected patients with acute cerebrovascular event and sleep-disordered breathing.
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Randomized Controlled Trial Comparative Study
PHANTOM-S: the prehospital acute neurological therapy and optimization of medical care in stroke patients - study.
Time from symptom onset to treatment is closely associated with the effectiveness of intravenous thrombolysis in acute ischemic stroke patients. Hospitals are encouraged to take every effort to shorten delay of treatment. Despite combined efforts to streamline procedures in hospitals to provide treatment as soon as possible, most patients receive tissue plasminogen activator with considerable delay and very few of them within 90 mins. Germany has an internationally acknowledged prehospital emergency care system with specially trained doctors on ambulances. We developed an ambulance equipped with a Computed Tomography (CT) scanner, point-of-care laboratory, teleradiological support, and an emergency-trained neurologist on board. In the Pre-Hospital Acute Neurological Therapy and Optimization of Medical care in Stroke Patients study, we aim at a reduction of the current alarm-to-needle time by prehospital use of tissue plasminogen activator in an ambulance. ⋯ Primary end point of the study is alarm-to-needle time. Secondary outcomes include thrombolysis treatment rates, modified Rankin scale after three-months, and alarm-to-imaging or alarm-to-laboratory time; safety aspects to be evaluated are mortality and rates of (symptomatic) intracerebral hemorrhage.
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Randomized Controlled Trial
The effectiveness of thrombolysis with intravenous alteplase for acute ischemic stroke in daily practice.
Thrombolysis with intravenous alteplase has been proven an effective treatment for patients with acute ischemic stroke in randomized clinical trials. In daily practice, the effect of thrombolysis may be less, and complications may occur more often. ⋯ Thrombolysis for ischemic stroke with intravenous alteplase is an effective treatment also in an unselected observational cohort of patients.
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Randomized Controlled Trial Multicenter Study
TESPI (Thrombolysis in Elderly Stroke Patients in Italy): a randomized controlled trial of alteplase (rt-PA) versus standard treatment in acute ischaemic stroke in patients aged more than 80 years where thrombolysis is initiated within three hours after stroke onset.
Intravenous (i.v.) thrombolysis with recombinant tissue-Plasminogen Activator (rt-PA) (alteplase) within three hours from symptom onset is the only approved treatment of pharmacological revascularization in acute ischaemic stroke. However, the current license limits the use of rt-PA to patients aged ≤80 years due to the lack of evidence of safety and efficacy of this treatment in the elderly from randomized clinical trials. This article describes the design of the Thrombolysis in Elderly Stroke Patients in Italy (TESPI) trial planned to fill the lack of controlled data on i.v. thrombolysis in this age category of stroke patients. ⋯ The primary efficacy end-point is the disability at day 90, dichotomized as a favourable outcome (modified Rankin Scale 0-2) or unfavourable outcome (modified Rankin Scale 3-6). The main primary safety end-point is symptomatic intracerebral haemorrhage defined as any hemorrhage at the 22-36 h post-treatment scan combined with neurological deterioration leading to an increase of one or more points at the National Institutes of Health Stroke Scale. The TESPI trial, with the protocol number FARM65KNKY, is registered in the European Union Drug Regulating Authorities Clinical Trials database with the number 2007-006177-88 and in the Stroke Trials Registry of the Washington University Internet Stroke Center.