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NCT00268112 Clinical Trial

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

Congenital Disorders Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00268112
Other study ID # 05-203
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2005
Last updated March 14, 2012
Start date January 2004
Est. completion date December 2006

Study information
Verified date December 2006
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- those patients who do not meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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