non-technical, languageĪ study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular disease Title of the trial for lay people, in easily understood, i.e. Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (seeĪ multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular diseaseĮstudio de fase IIb, multicéntrico, con doble enmascaramiento y controlado con placebo para evaluar la eficacia y la seguridad de macitentan en pacientes con insuficiencia cardíaca con fracción de eyección preservada y vasculopatía pulmonar. Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). En el análisis multivarioado, no encontramos significativas.Įl crecimiento auricular izquierdo severo y la edad mayor de 75 años mostraron tendencia significativa a recurrencia de infarto cerebral.Ĭrecimiento auricular izquierdo Embolic stroke of undetermined source Infarto cerebral Ischemic stroke Left atrial enlargement Recurrencia Stroke recurrence.Allows you to search for protocol and results information on: El grupo HRP mostró tendencia significatica hacia mayor recurrencia. 12 (18.8%) pacientes fueron de alto riesgo (HRP) y 52 (81.3%) de bajo riesgo (non- HRP). La mediana inicial de la escala de NIHSS fue de 3 putnos (rango de 0 a 27). Mediana de edad fue de 62 años (rango: 22-85 años) 33 (51.6%) fueron hombres. El descenlace primario fue recurrencia de infarto cerebral. La escala de Brown ESUS – AF fue utilizada para categorizar a los pacientes en riesgo alto (HRP puntaje > 2) y bajo riesgo (no-HRP: puntaje 0-1). La interpretación ecocardiográfica fue centralizada y cegada. Registramos los datos clínicos y ecocardiográficos. Sesenta y cuatro pacientes con diagnóstico confirmado de ESUS fueron seguidos por una mediana de seguimiento de 22 meses. Examinamos si el crecimiento aurícular izquierdo puede predecir recurrencia en pacientes con infarto embolico de origen indeterminado (ESUS). La patología atrial izquierda es factor de riesgo independiente para infarto cerebral y puede utilizarse para predecir fibrilación auricular. Patients with severe LAE who are 75 years old or older have a significant tendency to experience stroke recurrence. We found no differences in recurrence in a univariate analysis. We found a significant tendency toward recurrence among HRP versus non-HRP patients. Twelve (18.8%) patients were categorized as HRP. The median initial NIHSS score was three points (range: 0-27). The median age was 62 years (range: 22-85 years) and 33 (51.6%) were men. Stroke recurrence was the primary outcome. The Brown ESUS - AF score was used to categorize patients into high (human resource planning : score > 2) and low-risk patients (non-HRP score 0-1). The echocardiogram interpretation was performed centrally and blindly. Clinical data and echocardiogram findings were recorded. Sixty-four patients with a confirmed diagnosis of ESUS were followed for a median of 22 months. We examine whether left atrial enlargement (LAE) could predict stroke recurrence in patients with embolic stroke of undetermined source (ESUS). Left atrial disease is an independent risk factor for ischemic stroke and can be used to predict atrial fibrillation (AF).
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