Stroke; a journal of cerebral circulation
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Randomized Controlled Trial Multicenter Study Comparative Study
Recovery of cognitive function after surgery for aneurysmal subarachnoid hemorrhage.
Abnormalities in neurocognitive function are common after surgery for aneurysmal subarachnoid hemorrhage, even among patients with good functional outcomes. The time course of neurocognitive recovery, along with the long-term effects of mild intraoperative hypothermia (33 degrees C) and aneurysm location, is unknown. We determined these in a subset of subarachnoid hemorrhage patients enrolled in the Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST). ⋯ In this population, cognitive improvement continued beyond 3 months, with a plateau between 9 and 15 months. This was not affected by the use of intraoperative hypothermia or anatomical location of aneurysm.
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Multicenter Study Comparative Study
Serum cellular fibronectin and matrix metalloproteinase-9 as screening biomarkers for the prediction of parenchymal hematoma after thrombolytic therapy in acute ischemic stroke: a multicenter confirmatory study.
Plasma levels of cellular fibronectin (c-Fn) > or =3.6 microg/mL and of matrix metalloproteinase-9 (MMP-9) > or =140 ng/mL have been associated with parenchymal hematoma (PH) after treatment with tissue-type plasminogen activator (t-PA) in patients with acute ischemic stroke. In this prospective study, we sought to validate the predictive capacity of the preestablished cutoff values of these biomarkers for PH in a larger series of patients. ⋯ This prospective study confirmed the high sensitivity and negative predictive value, with retained good specificity, of c-Fn and MMP-9 for the prediction of PH in patients treated with t-PA. Development of faster analytic methods will prove the applicability of these biomarkers in routine clinical practice.
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The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.
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Randomized Controlled Trial Multicenter Study Comparative Study
Long-term outcome after angioplasty and stenting for symptomatic vertebral artery stenosis compared with medical treatment in the Carotid And Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomized trial.
The long-term outcome of endovascular intervention compared with best medical management of patients with symptomatic vertebral artery stenosis is uncertain. We therefore compared these treatments in a randomized trial with long-term follow-up. ⋯ Patients with vertebral artery stenosis were more likely to have carotid territory stroke and myocardial infarction during follow-up than have recurrent vertebrobasilar stroke. The trial failed to show a benefit of endovascular treatment of vertebral artery stenosis, but the numbers of patients included was small. Larger randomized trials are required to determine whether vertebral artery stenting is justified in patients at higher risk of vertebrobasilar stroke. Treatment of patients with vertebral artery stenosis should focus on global reduction of vascular risk, including prevention of carotid territory stroke and myocardial infarction.