Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486070
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2007-06-12
Brief Title:
Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Proposal for Retrospective Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
conclusions drawn manuscript written
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective review of charts and echocardiograms of our patients with Total Anomalous Pulmonary Venous Connection TAPVC The Childrens Surgical and non-invasive Echo databases will be used to determine all TAPVC patients Childrens Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1 2002 and November 26 2006 will be reviewed We anticipate approximately 40 patients
We hypothesize that the presence of descending aortic flow reversal correlates with a higher morbidity and mortality in TAPVC
We hypothesize that the presence of descending aortic flow reversal correlates with a higher morbidity and mortality in TAPVC
Detailed Description:
Total anomalous pulmonary venous connection TAPVC is a congenital cardiac anomaly in which the pulmonary veins fail to connect to the usual anatomic location the left atrium This may lead to critical cardio-pulmonary failure and extreme cyanosis This condition usually requires urgent surgical repair In many cases the pulmonary veins may be obstructed leading to severe pulmonary hypertension and low cardiac output which may be acutely life-threatening In these cases emergent surgical repair is undertaken in the newborn period Patients with TAPVC may have poor prognosis which may be difficult to predict
We have made the unusual and previously unreported observation by echocardiography of flow reversal in the upper descending aorta indicating extremely reduced left ventricular output in patients with TAPVC some of whom have had a poor outcome This has led to the hypothesis that descending aortic flow reversal portends a poor prognosis in TAPVC
The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal We also would evaluate the presence of other associated cardiac anomalies
The second step of the study would be to review the clinical charts of the above patients to evaluate for serious co-morbidities and mortality Outcome measures would include mortality chronic lung disease continued oxygen requirement recurrent respiratory infections listing for transplantation cardiopulmonary arrest or requirement for ECMO
We have made the unusual and previously unreported observation by echocardiography of flow reversal in the upper descending aorta indicating extremely reduced left ventricular output in patients with TAPVC some of whom have had a poor outcome This has led to the hypothesis that descending aortic flow reversal portends a poor prognosis in TAPVC
The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal We also would evaluate the presence of other associated cardiac anomalies
The second step of the study would be to review the clinical charts of the above patients to evaluate for serious co-morbidities and mortality Outcome measures would include mortality chronic lung disease continued oxygen requirement recurrent respiratory infections listing for transplantation cardiopulmonary arrest or requirement for ECMO
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