- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00926874
Comparative Study of Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome (AVC/SCA)
A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome
A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion.
The proposed study aims to investigate and analyse the differences in functional and structural arterial properties between the patients who presented an ischaemic stroke and those who presented ACS. The hypothesis is that the patients in both groups will present differences partly in terms of their "traditional" cardiovascular risk factors, but also in terms of their arterial properties. All of the confounding factors studied (cardiovascular risk factors, treatments) will be taken into account in order to explain the differences in the arterial properties found between the two groups. Furthermore, the prevalence of signs and symptoms in the two populations will be studied.
Descripción general del estudio
Estado
Descripción detallada
A comparative study of structural and functional arterial properties after an ischaemic stroke or an acute coronary syndrome
Objectives:
Primary:
- To determine whether there is a difference in the biomechanical properties of the carotid arteries, assessed by studying their stiffness, after an acute vascular event, depending on whether the event is an ischaemic stroke (either a full stroke or a transitory ischaemic attack (TIA)) or an acute coronary syndrome (ACS).
Secondary:
- To determine whether there is a difference in aortic stiffness and brachial endothelial function after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
- To compare the blood pressure (BP) levels and the vascular parameters of the two patient groups (the ischaemic stroke group and the ACS group).
- To determine whether there is a difference between the respiratory parameters recorded during sleep after an acute vascular event, depending on whether the event is an ischaemic stroke (full stroke or TIA) or an ACS.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Grenoble, Francia
- Reclutamiento
- University Hospital
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Contacto:
- Baguet Jean-Philippe, Professor
- Número de teléfono: 0033476768480
- Correo electrónico: JPBaguet@chu-grenoble.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Male and female patients
- Between 40 and 70 years of age
- Who have given their written consent
- Who have presented the following between 5 and 30 days prior to inclusion:
- either an ischaemic stroke (full stroke or TIA) that has been stabilised from a neurological point of view, with no haemorrhage but with direct signs of ischaemia on the cerebral imaging (computed tomography or MRI), diagnosed during patient questioning and/or the clinical examination;
- or an ACS that has been stabilised from a cardiological point of view, with troponin elevation in at least 2 samples and/or ECG changes that indicate acute myocardial ischaemia, diagnosed during patient questioning.
- Who are affiliated to the French social security system
Exclusion Criteria:
For patients included in the ACS group
- Stroke less than 6 months ago
- Coronary bypass between the start of their hospitalisation for ACS and inclusion
For patients included in the stroke group
- Emboligenic heart disease
- ACS less than 6 months ago
For all patients
- Atrial fibrillation or flutter, or frequent extrasystole (more than 10/minute) upon inclusion
- History of surgery or carotid stenting
- Very reduced mobility meaning that they cannot remain standing without assistance or without using a walking stick
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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1
patients who presented an ischaemic stroke(full stroke or TIA)
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2
patients who present an acute coronary syndrome (ACS).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
biomechanical properties of the carotid arteries
Periodo de tiempo: 1-6 months
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1-6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
aortic stiffness and brachial endothelial function
Periodo de tiempo: 1-6 months
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1-6 months
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blood pressure (BP) levels and the vascular parameters
Periodo de tiempo: 1-6 months
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1-6 months
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respiratory parameters recorded during sleep
Periodo de tiempo: 1-6 months
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1-6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: BAGUET Jean Philippe, Professor, University Hospital, Grenoble
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Isquemia miocardica
- Enfermedades cardíacas
- 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
- Enfermedad
- Isquemia cerebral
- Infarto
- Infarto cerebral
- Carrera
- Síndromes de apnea del sueño
- Apnea del Sueño Obstructiva
- Síndrome
- Accidente cerebrovascular isquémico
- Isquemia
- Infarto cerebral
- El síndrome coronario agudo
Otros números de identificación del estudio
- 0401 (Abbott Vascular)
- DGS 2008/0443
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