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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165945
• Other study ID #: 075-2004
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: March 30, 2012
• Start date: June 2004
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Informed consent

• meet MRI eligibility inclusion criteria

Exclusion Criteria:

• Not having a cardiac MRI

• No informed consent

• not meeting MRI eligibility exclusion criteria

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if the 4-D visualization software is beneficial in the investigators' understanding and management of complex congenital heart lesions and their associated hemodynamics/anatomy		throughout study	No
Secondary	To study the impact and role of 4-D Visualization on surgical planning and outcome		entire study	No