4-D Visualization in Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population - Full Text View

Purpose

In this study, the investigators wish to use images obtained from standard of care cardiac MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different computer in order to analyze them with a new computer. The investigators are hoping to better their understanding and management of complex congenital heart disease.

Condition	Intervention
Congenital Heart Disease	Procedure: 4-D visualization computer software

MedlinePlus related topics:

Heart Diseases MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	Using 4-D Visualization Software With Magnetic Resonance Images in the Congenital Heart Disease Population

Further study details as provided by Emory University:

Primary Outcome Measures:

To determine if the 4-D visualization software is beneficial in the investigators' understanding and management of complex congenital heart lesions and their associated hem [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	June 2004
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Using new computer software to analysis MRI data

Detailed Description:

All patients enrolled in this study will be receiving standard of care cardiac MRI as prescribed by their physician. These MRI DICOM images will be transferred to a SGI Fuel workstation, where they will be manipulated using the newly developed 4-D Visualization software. No additional scanner time or new imaging sequences are required as presently prescribed sequences and produced data can be analyzed. The workstation is designed to include acceleration hardware for volume rendering, and was developed for advanced cardiac MRI viewing.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled for a cardiac MRI at Children's Healthcare of Atlanta
Informed consent

Exclusion Criteria:

Not having a cardiac MRI
No informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165945

Contacts


Contact: W. James Parks, MD	404-727-2542	parksj@kidsheart.com

Contact: Charles Kitchen, BS	404-712-0896	ckitche@emory.edu

Locations


United States, Georgia
	Children's Healthcare of Atlanta	Recruiting
	Atlanta, Georgia, United States, 30322
	Contact: W.James Parks, MD 404-727-2542 parksj@kidsheart.com
	Contact: Charles Kitchen, BS 404-712-0896 ckitche@emory.edu
	Principal Investigator: W.James Parks, MD
	Sub-Investigator: Denver Sallee, MD
	Sub-Investigator: Marijn Brummer, PhD

Sponsors and Collaborators

Emory University

Children's Healthcare of Atlanta

Investigators


Principal Investigator:	W.James Parks, MD	Emory University and Children's Healthcare of Atlanta

More Information

Responsible Party:	Emory University ( James Parks, MD )
Study ID Numbers:	075-2004
First Received:	September 12, 2005
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00165945
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

pediatric, cardiology, diagnostic imaging

Study placed in the following topic categories:

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Emory University Children's Healthcare of Atlanta
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00165945