Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Ventricular Synchrony in Pediatric Patients

30 de mayo de 2012 actualizado por: Patricio A. Frias, MD, Emory University

A Single Center Prospective, Pilot Study Examining the Non-invasive Evaluation of Ventricular Synchrony in Pediatric Patients

At Children's Healthcare of Atlanta, children who have irregular heart rhythms are often referred for evaluation. Sometimes they also need a procedure to correct their irregular heart rhythm. An echocardiogram is routinely used as part of their evaluation and follow-up. The echocardiogram including Tissue Doppler Imaging (TDI) works by bouncing sound waves off the heart similar to radar. A new echocardiogram technology, Tissue Synchronization Imaging (TSI), should help doctors look at heart function compared to heart rhythm. All three of these are noninvasive, which means they work from a probe outside the body and are not painful.

The purpose of this study is to see how Tissue Synchronization Imaging works in patients with heart rhythm problems. We will use patients who have a heart irregularity. We will also look at children and young adults with normal heart function to establish normal values for TSI.

All pediatric patients we approach for this study will receive an echocardiogram recommended by their cardiologist (standard of care), plus TSI, a new part of a heart ultrasound The young adult population will undergo a heart ultrasound plus TSI. This young adult population will be selected from medical students at Emory University. During the consent process, the medical students will be informed that participation is voluntary and if they decide not to participate, it will not affect their grades, etc.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

There is a growing body of evidence that interventricular dyssynchrony results in abnormal ventricular mechanics that may be detrimental to myocardial performance.(1; 2) Adult patients with LBBB, dilated cardiomyopathy and CHF are increasingly being treated with a novel pacing technique in order to restore electrical and mechanical synchrony.(3-5) This technique, biventricular or resynchronization pacing, involves the insertion of a specialized cardiac pacing system that not only maintains atrioventricular synchrony, but also restores interventricular synchrony by simultaneously activating the right and left ventricles. There have been a number of clinical trials (MIRACLE, MUSTT, INSYNC) that have revealed marked clinical improvement in adult patients with moderate-to-severe CHF.(6-8) There have been a few small reports of the acute effects of biventricular pacing in pediatric patients with acquired interventricular dysynchrony either from repair or palliation of congenital heart defects, or from chronic standard pacing from one ventricular chamber (single-site ventricular pacing).(9-11) One of the main hurdles encountered when evaluating these patients is the lack of reliable, reproducible non-invasive imaging modalities. Recent reports have shown promising results with a relatively new technique known as tissue Doppler imaging (TDI).(12-14) TDI echocardiography has recently been employed as a non-geometric measure of myocardial systolic and diastolic performance for both the left and the right ventricles. Utilizing low velocity signals from discrete points on the myocardial walls, motion can be assessed under a variety of conditions non-invasively. Additionally when two points along a ventricular wall are simultaneously assayed, the relative motion between the two points can estimate myocardial systolic strain in the direction of the Doppler sound beam. This technique eliminates any variation due to the translational motion of the heart.

Tissue synchronization can be assessed by the timing of peak systolic motion of different points along the myocardium relative either to the QRS of the electrocardiogram or to the mechanical indicators of systole such as aortic valve opening. Recent advances in software design have now created technology that simultaneously depicts the peak velocities of the entire myocardium viewed in a 2-dimensional echo image. This promotes easy identification of any dysynchronous segments. By subsequently applying discrete cursors to these areas, graphic patterns of both velocity and direction of myocardial motion can be drawn for quantitative analysis. The application of these new sophisticated tools will allow better analysis of electromechanical dysynchrony and may enable definition of criteria, which can be used to identify those patients who will or will not benefit from cardiac resynchronization therapy.

We have identified 4 groups of patients that will allow us to prospectively and systematically evaluate TSI in this young population. The first group is those patients with supraventricular tachycardia and the Wolff-Parkinson-White (WPW) syndrome. These patients have an accessory AV connection (AC) that allows electrical activity to bypass the normal AV node and excite the ventricles prematurely. In doing so, the result is a loss of the normal, midline ventricular activation pattern for a dysynchronous activation pattern. There have been small reports of this chronic ventricular dysynchrony potential playing a role in depressed myocardial performance.(15) Standard therapy for patients with WPW and clinical SVT includes invasive intracardiac electrophysiology study (EPS) with possible radiofrequency ablation (RFA) in order to eliminate the AC. These patients are then left with normal conduction over the AV node, presumably restoring the midline activation sequence.

The second group of patients is those children with SVT and no evidence of ventricular preexcitation (i.e., no WPW). These patients have a normal, midline ventricular activation pattern in sinus rhythm. Standard treatment for children afflicted with these variants of SVT would also include EPS and RFA. As part of the standard EPS, these patients receive intermittent atrial and ventricular pacing. The result of the transient ventricular pacing is presumably a dysynchronous activation pattern that could be evaluated with TSI. With pacing off, the normal activation pattern should be restored. Therefore, these patients will also serve as their own controls.

The third group is essentially normal (normal 4 chamber anatomy) pediatric patients who have been referred for an echocardiogram to evaluate a possible heart murmur, syncope or chest pain. Their data will be used to establish normal pediatric values for TSI.

The fourth group is normal (normal 4 chamber anatomy) young adult subjects who will be recruited for participation in this study. Their data will be used to establish normal adult values for TSI. These values or results will not be compared to the other three pediatric groups.

Tipo de estudio

De observación

Inscripción (Actual)

145

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

    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Children's Healthcare of Atlanta at Egleston

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

We are currently only enrolling those patients with the diagnosis of SVT who are scheduled for an electrophysical study at Children's Healthcare of Atlanta Egleston Campus.

Descripción

Inclusion Criteria:

Any pediatric patient already referred for EPS and possible RFA at Children's Healthcare of Atlanta for the following diagnoses:

  • Non-preexcited supraventricular tachycardia
  • Atrioventricular Node Reentrant Tachycardia (AVNRT)
  • Atrioventricular Reentry Tachycardia (AVRT) utilizing a concealed AC
  • Atrial Flutter
  • Wolff-Parkinson-White syndrome (WPW)
  • Ventricular tachycardia with structurally normal hearts with normal function We will also be enrolling young adult subjects who will be recruited for participation. -

Exclusion Criteria:

-

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Patricio Frias, MD, Emory University

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.

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 junio de 2004

Finalización primaria (Actual)

1 de diciembre de 2009

Finalización del estudio (Actual)

1 de diciembre de 2009

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2005

Publicado por primera vez (Estimar)

14 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de junio de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

30 de mayo de 2012

Última verificación

1 de mayo de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 417-2004

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. .

Ensayos clínicos sobre Irregular Heart Rate

3
Suscribir