We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection

This study has been terminated.
(conclusions drawn, manuscript written)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486070
First Posted: June 13, 2007
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Healthcare of Atlanta
  Purpose

This is a retrospective review of charts and echocardiograms of our patients with Total Anomalous Pulmonary Venous Connection (TAPVC). The Children's Surgical and non-invasive Echo databases will be used to determine all TAPVC patients. Children's 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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Proposal for Retrospective Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection

Resource links provided by NLM:


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

Estimated Enrollment: 40
Study Start Date: December 2006
Study Completion Date: September 2007
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
TAPVC patients
Criteria

Inclusion Criteria:

  • Children's 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.

The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal.

Exclusion Criteria:

  • those who do not fall under the Inclusion Criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486070


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

Responsible Party: Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00486070     History of Changes
Other Study ID Numbers: 06-197
First Submitted: June 12, 2007
First Posted: June 13, 2007
Last Update Posted: March 16, 2012
Last Verified: January 2008

Keywords provided by Children's Healthcare of Atlanta:
cardiac anomaly
pulmonary veins
cyanosis
flow reversal
TAPAVC

Additional relevant MeSH terms:
Scimitar Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Congenital Abnormalities