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

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
W. James Parks, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00165945
First received: September 12, 2005
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  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
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using 4-D Visualization Software With Magnetic Resonance Images in the Congenital Heart Disease Population

Resource links provided by NLM:

U.S. FDA Resources

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 hemodynamics/anatomy [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the impact and role of 4-D Visualization on surgical planning and outcome [ Time Frame: entire study ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: June 2004
Study Completion Date: March 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Pediatrics patients in all age groups evaluated with MRI for complex congenital cardiovascular lesions and associated hemodynamics. These are patients coming in for standard of care cardiac MRI's

Criteria

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

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
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

No publications provided

Responsible Party: W. James Parks, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00165945     History of Changes
Other Study ID Numbers: 075-2004
Study First Received: September 12, 2005
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatric, cardiology, diagnostic imaging using MRI

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 17, 2013