Stroke; a journal of cerebral circulation
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Randomized Controlled Trial Comparative Study
Challenges of decision making regarding futility in a randomized trial: the Interventional Management of Stroke III experience.
Interventional Management of Stroke (IMS) III is a randomized, parallel arm trial comparing the approach of intravenous tissue-type plasminogen activator followed by endovascular treatment with intravenous tissue-type plasminogen activator alone in patients with acute ischemic stroke presenting <3 hours of symptom onset. The trial intended to enroll 900 subjects to ensure adequate statistical power to detect an absolute 10% difference in the percentage of subjects with good outcome, defined as modified Rankin Scale score of 0 to 2 at 3 months. In April 2012, after 656 subjects were randomized, further enrollment was terminated by the National Institute of Neurological Disorders and Stroke based on the prespecified criterion for futility using conditional power<20%. ⋯ http://www.clinicaltrials.gov. Unique identifier: NCT00359424.
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Randomized Controlled Trial Multicenter Study Comparative Study
Effects of extracranial-intracranial bypass for patients with hemorrhagic moyamoya disease: results of the Japan Adult Moyamoya Trial.
About one half of those who develop adult-onset moyamoya disease experience intracranial hemorrhage. Despite the extremely high frequency of rebleeding attacks and poor prognosis, measures to prevent rebleeding have not been established. The purpose of this study is to determine whether extracranial-intracranial bypass can reduce incidence of rebleeding and improve patient prognosis. ⋯ http://www.umin.ac.jp/ctr/index.htm. Unique identifier: C000000166.
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Randomized Controlled Trial Multicenter Study
Early intensive versus minimally invasive approach to postoperative hemodynamic management after subarachnoid hemorrhage.
The results of previous studies suggest that early goal-directed fluid therapy (EGDT) reduces delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage, but the effects of EGDT on clinical outcomes are still unclear. This study aimed to determine whether EGDT improves outcomes compared with standard less-invasive hemodynamic therapy. ⋯ http://www.clinicaltrials.gov. Unique identifier: UMIN000007509.
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Randomized Controlled Trial
Cerebral perfusion and blood pressure do not affect perihematoma edema growth in acute intracerebral hemorrhage.
The pathogenesis of perihematoma edema in intracerebral hemorrhage (ICH) is unknown but has been hypothesized to be ischemic. In the ICH Acutely Decreasing Arterial Pressure Trial (ICH ADAPT), perihematoma cerebral blood flow (CBF) was reduced but was unaffected by blood pressure (BP) reduction. Using ICH ADAPT data, we tested the hypotheses that edema growth is associated with reduced CBF and lower systolic BP. ⋯ http://www.clinicaltrials.gov. Unique identifier: NCT00963976.
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Comparative Study
Is the long-term prognosis of transient ischemic attack or minor ischemic stroke affected by the occurrence of nonfocal symptoms?
In patients with a transient ischemic attack or ischemic stroke, nonfocal neurological symptoms, such as confusion and nonrotatory dizziness, may be associated with a higher risk of vascular events. We assessed the relationship between nonfocal symptoms and the long-term risk of vascular events or death in patients with a transient ischemic attack or minor ischemic stroke. ⋯ This trial was not registered because enrollment began before July 1, 2005.