International journal of stroke : official journal of the International Stroke Society
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Obstructive sleep apnea (OSA) is associated with increased risk of cardiovascular disease. Continuous positive airway pressure (CPAP) delivered via a nasal mask during sleep immediately alleviates obstructive apneas and improves sleep quality and daytime somnolence. However, there is uncertainty as to whether such treatment can modify CV risk and disease. ⋯ The pre-specified statistical analysis plan (SAP) for the main analyses is presented. This SAP was finalised before patient follow-up was completed and before any unblinding of the data. The SAP outlines details of the primary, secondary and tertiary outcomes, together with planned subgroup and exploratory analyses.
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The early recurrence of neurological symptoms (NR) after urgent aggressive best medical therapy (BMT) in symptomatic carotid stenosis is not well documented. ⋯ Urgent aggressive BMT after index-event is associated with a significant reduction in the risk of early NR in CEA candidates. The early risk of recurrent stroke in patients with symptomatic significant carotid stenosis is dramatically reduced after urgent aggressive BMT in specialised stroke clinics.
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Cerebral ischemia is a leading cause of disability worldwide and no other effective therapy has been validated to date than intravenous thrombolysis. In this context, many preclinical models have been developed and recent advances in preclinical imaging represent promising tools. Thus, we proposed here to characterize in vivo time profiles of cerebral blood flow, blood-brain barrier disruption and apoptosis following a transient middle cerebral artery occlusion in rats using SPECT/CT imaging. ⋯ Using SPECT/CT imaging, we showed that after transient middle cerebral artery occlusion in rat there was a sustained decrease in cerebral blood flow followed by blood-brain barrier disruption preceding meanwhile apoptosis. Rodent SPECT/CT imaging of cerebral blood flow, blood-brain barrier disruption and apoptosis appears to be an efficient tool for evaluating neuroprotective drugs and regenerative therapies against cerebral ischemia and time-windows for therapeutic intervention.
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Randomized Controlled Trial Multicenter Study Comparative Study
Acute Stroke or Transient Ischemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes (SOCRATES) trial: rationale and design.
The risk of recurrent ischemia is high in the acute period after ischemic stroke and transient ischemic attack. Aspirin is recommended by guidelines for this indication, but more intensive antiplatelet therapy may be justified. ⋯ The SOCRATES trial fulfills an important clinical need by evaluating a potent antiplatelet agent as a superior alternative to current standard of care in patients presenting acutely with ischemic stroke or transient ischemic attack.
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Randomized Controlled Trial
Statistical analysis plan for evaluating low- vs. standard-dose alteplase in the ENhanced Control of Hypertension and Thrombolysis strokE stuDy (ENCHANTED).
The ENhanced Control of Hypertension And Thrombolysis strokE stuDy trial is a 2 × 2 quasi-factorial active-comparison, prospective, randomized, open, blinded endpoint clinical trial that is evaluating in thrombolysis-eligible acute ischemic stroke patients whether: (1) low-dose (0·6 mg/kg body weight) intravenous alteplase has noninferior efficacy and lower risk of symptomatic intracerebral hemorrhage compared with standard-dose (0·9 mg/kg body weight) intravenous alteplase; and (2) early intensive blood pressure lowering (systolic target 130-140 mmHg) has superior efficacy and lower risk of any intracerebral hemorrhage compared with guideline-recommended blood pressure control (systolic target <180 mmHg). ⋯ We have developed a predetermined statistical analysis plan for the ENhanced Control of Hypertension And Thrombolysis strokE stuDy alteplase dose arm which is to be followed to avoid analysis bias arising from prior knowledge of the study findings.