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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02141269
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)
Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).
The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.
We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:
- Ejection fraction: estimates how well the heart is squeezing/functioning.
- Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
- Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
- Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
- Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
- Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
- Pericardial effusion: excessive fluid in the sack around the heart.
The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.
A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Green Hospital
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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:
- All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
- Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
- Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
- Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.
Exclusion Criteria:
- Subjects who had a limited transthoracic echocardiography (i.e limited views)
- Vscan imaging not attempted for a certain parameter
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparison of HHE and TTE results
Periodo de tiempo: 1 time
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Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.
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1 time
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Topol, MD, Scripps Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 12-5906
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