Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy (SAS-CARE)
23 de octubre de 2015 actualizado por: Prof. Claudio Bassetti
Sleep Disordered Breathing in TIA/Ischemic Stroke: Effects on Short- and Long-term Outcome and CPAP Treatment Efficacy: an Open, Observational, Clinical, Multicentre Trial With a Randomized Arm
The study aims to observe the short term effect (3-month) of sleep disordered breathing (SDB) on cardiovascular parameters, heart rate variability, endothelial function and surrogate markers of atherosclerosis after acute cerebrovascular events (ACE).
The long-term effect (6-24-month) of Continuous Positive Airway Pressure (CPAP) on clinical vascular outcome, cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability and endothelial function after ACE is observed over 24 months.
A preventive effect of CPAP therapy on cerebro-vascular events in patients with moderate-severe obstructive SDB without sleepiness after ictus or transient ischaemic attack will be evaluated.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events.
Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events.
The SAS CARE 1 study is planned to verify whether or not sleep disordered breathing has a detrimental 3 months effect on cardiovascular functions and markers after acute cerebrovascular events. The SAS CARE 2 study is designed to address whether or not the treatment of sleep disordered breathing with CPAP reduces the combined rate of mortality, stroke, cardiovascular events (myocardial infarction/revascularisation/instable angina/ hospitalisation for heart insufficiency) over a 24 months period in patients after acute cerebrovascular events.
Tipo de estudio
Intervencionista
Inscripción (Actual)
246
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Münster, Alemania
- University Hospital Münster
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Lombardia
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Milan, Lombardia, Italia, I-20162
- Dipartimento Neuroscienze, Ospedale Niguarda
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Bern, Suiza, CH-3010
- Inselspital, Universitätsklinik für Pneumologie
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Ticino
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Bellinzona, Ticino, Suiza, CH-6500
- Ospedale San Giovanni
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Lugano, Ticino, Suiza, CH-6900
- Neurocenter of Southern Switzerland, Ospedale Civico
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
35 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- ≥ 35 years old and < 75 years old
- with clinical diagnosis of TIA or ischemic stroke
- admitted in a Stroke Unit within 2 days from onset of symptoms
- or with TIA or ischemic stroke within the last 60-90 days
- signed Informed Consent
Exclusion Criteria:
- with unstable clinical situation (cardio-respiratory or life-threatening medical conditions)
- currently on CPAP or on CPAP during the last 3 months before stroke
- with non-ischemic events (intracerebral/subarachnoid haemorrhage)
- Patients with coma/stupor
- with borderline obstructive SDB (AHI 10-19)
- with any condition that interferes with the acceptance of CPAP treatment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: CPAP in sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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Sin intervención: no CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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Comparador activo: CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported
Periodo de tiempo: 24 monts after stroke
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New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke
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24 monts after stroke
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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CPAP-Compliance measured by hours of usage
Periodo de tiempo: up to 24 months after stroke
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Compliance is monitored for the use of the CPAP by the pulmonary specialist at the patients' routine visits 2-3, 4-6 weeks, 3-6 months, 12 and 24 months after randomisation.
The hours ofuse are registered by a chip inserted in the device.
Good compliance is, if the device was used > 10 hours per day.
Satisfactory compliance is defined for a use of the CPAP for at least 4 hours per night during at least 70% of the nights.
Insufficient compliance is defined as < 4 hours per night or less than 70% of nights.
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up to 24 months after stroke
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Blood pressure profile (systolic mean, diastolic mean, max, min: general, day, night) measured in mmHg for every patient by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months
Periodo de tiempo: up to 12 months after stroke
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Mean systolic and diastolic BP values, minimal and maximum values will be calculated for each patient for each period of time [after stroke: whole measuring period, (36 h) first night, second day, and second night after stroke; 3 months after stroke: whole period (24 h), day, night].
In addition same measurements will be made 12 months after stroke The occurrence of dippers will be registered at baseline (after stroke) and at 3 months.
A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data).
An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered.
A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data).
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up to 12 months after stroke
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Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months
Periodo de tiempo: up to 12 months after stroke
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The occurrence of dippers will be registered at baseline (after stroke) and at 3 months and 12 months after stroke.
A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data).
An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered.
A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data).
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up to 12 months after stroke
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Claudio Bassetti, Professor, Universitätsspital Bern (Inselspital) und Universität Bern
- Silla de estudio: Carlo Cereda, Capo CLinica, Neurocentre of Southern Switzerland, Ospedale Civico
- Silla de estudio: Sebastian Ott, MD, Pneumology, University Hospital, Bern
- Silla de estudio: Lino Nobili, Prof. MD, Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy
- Silla de estudio: Mauro Manconi, MD, Neurocentre of Southern Switzerland, Ospedale Civico
- Silla de estudio: Peter Young, Prof. MD, Universitätsklinik Münster, Zentrum für Schlafmedizin
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Martinez-Garcia MA, Soler-Cataluna JJ, Ejarque-Martinez L, Soriano Y, Roman-Sanchez P, Illa FB, Canal JM, Duran-Cantolla J. Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5-year follow-up study. Am J Respir Crit Care Med. 2009 Jul 1;180(1):36-41. doi: 10.1164/rccm.200808-1341OC. Epub 2009 Apr 30.
- Bassetti C, Aldrich MS, Chervin RD, Quint D. Sleep apnea in patients with transient ischemic attack and stroke: a prospective study of 59 patients. Neurology. 1996 Nov;47(5):1167-73. doi: 10.1212/wnl.47.5.1167.
- Bassetti C, Aldrich MS. Sleep apnea in acute cerebrovascular diseases: final report on 128 patients. Sleep. 1999 Mar 15;22(2):217-23. doi: 10.1093/sleep/22.2.217.
- Bassetti CL, Milanova M, Gugger M. Sleep-disordered breathing and acute ischemic stroke: diagnosis, risk factors, treatment, evolution, and long-term clinical outcome. Stroke. 2006 Apr;37(4):967-72. doi: 10.1161/01.STR.0000208215.49243.c3. Epub 2006 Mar 16.
- Pace M, Camilo MR, Seiler A, Duss SB, Mathis J, Manconi M, Bassetti CL. Rapid eye movements sleep as a predictor of functional outcome after stroke: a translational study. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy138.
- Manconi M, Zavalko I, Cereda C, Pisarenco I, Ott S, Fulda S, Bassetti CL. Longitudinal polysomnographic assessment from acute to subacute phase in infratentorial versus supratentorial stroke. Cerebrovasc Dis. 2014;37(2):85-93. doi: 10.1159/000356323. Epub 2014 Jan 16.
- Cereda CW, Petrini L, Azzola A, Ciccone A, Fischer U, Gallino A, Gyorik S, Gugger M, Mattis J, Lavie L, Limoni C, Nobili L, Manconi M, Ott S, Pons M, Bassetti CL. 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. Int J Stroke. 2012 Oct;7(7):597-603. doi: 10.1111/j.1747-4949.2012.00836.x. Epub 2012 Jul 19.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2010
Finalización primaria (Anticipado)
1 de abril de 2016
Finalización del estudio (Anticipado)
1 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
1 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
1 de abril de 2010
Publicado por primera vez (Estimar)
2 de abril de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
23 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Apnea
- Trastornos de la respiración
- Trastornos del Sueño Intrínsecos
- Disomnias
- Trastornos del sueño y la vigilia
- Isquemia cerebral
- Infarto
- Infarto cerebral
- Carrera
- Síndromes de apnea del sueño
- Accidente cerebrovascular isquémico
- Isquemia
- Infarto cerebral
Otros números de identificación del estudio
- EOC.NC.10.01
- 320030-125069/1 (Otro número de subvención/financiamiento: Swiss National Science Foundation (SNSF))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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