Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268112
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2005-12-20
Brief Title:
Resynchronization of Left Ventricular Contraction After Reimplantation of Anomalous Left Coronary Artery
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sufficient data collected for analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
These questions need data from quantitative serial tissue Doppler observations of patients from pre-operative to late post-operative follow-up
Detailed Description:
We have previously studied at Childrens 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 Childrens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None