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Resynchronization of Left Ventricular Contraction After Reimplantation of Anomalous Left Coronary Artery

This study has been terminated.
(sufficient data collected for analysis)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00268112
First received: December 20, 2005
Last updated: March 14, 2012
Last verified: December 2006
History of Changes
  Purpose

Spontaneous resynchronization of dyskinetic segments of the left ventricle occurs after coronary bypass surgery in adults and has been shown in some children. It is, however, unknown what degree of dyskinesis is likely to be reversible in infants with ischemia from anomalous coronary arteries and what criteria would indicate that a resynchronization strategy of biventricular pacing might be needed.

These questions need data from quantitative serial tissue Doppler observations of patients from pre-operative to late post-operative follow-up.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Resynchronization of Left Ventricular Contraction After Re-implantation of Anomalous Left Coronary Artery From the Pulmonary Artery (ALCAPA) Evaluated by Tissue Doppler Imaging

Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 3
Study Start Date: January 2004
Study Completion Date: December 2006
Detailed Description:

We have previously studied, at Children's Healthcare of Atlanta, Egleston Hospital, 2 patients with ALCAPA and one other patient is currently enrolled in a prospective study after recent surgery, also at Children's Healthcare of Atlanta. We propose to study these 3 patients with this rare defect concurrently with their routine echocardiographic evaluations. Data will then be taken off-line for analysis.

Standard deviations of times to peak contraction velocity will be assessed for twelve cardiac segments. These will be reevaluated at follow up intervals after surgery on previously obtained echocardiograms. Those subjects in whom improvement of cardiac function, Left Ventricular Ejection Fraction (LVEF) and mitral regurgitation is seen will be compared to those in whom no improvement occurs.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiac pediatric patients

Criteria

Inclusion Criteria:

  • Re-implantation of an anomalous left coronary artery from the pulmonary artery

Exclusion Criteria:

  • those patients who do not meet inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268112

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Derek A. Fyfe, MD, PhD Sibley Heart Center Cardiology at Children's Healthcare of Atlanta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268112     History of Changes
Other Study ID Numbers: 05-203
Study First Received: December 20, 2005
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
pediatric
cardiac
ALCAPA
Tissue Doppler Imaging

ClinicalTrials.gov processed this record on May 16, 2013