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Magnetic Resonance Imaging of Atrial Septal Defects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498446
First Posted: July 10, 2007
Last Update Posted: June 19, 2013
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:
Duke University
  Purpose
An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.

Condition
Atrial Septal Defect

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Imaging of Atrial Septal Defects by Velocity Encoded Cardiovascular Magnetic Resonance

Further study details as provided by Duke University:

Enrollment: 44
Study Start Date: July 2002
Study Completion Date: July 2004
Detailed Description:

Background: Atrial septal defect (ASD) flow can be measured indirectly by velocity-encoded cardiovascular magnetic resonance (veCMR) of the pulmonary artery and aorta (Qp/Qs). Imaging the secundum ASD en face could potentially enable direct flow measurement and, additionally, provide valuable information regarding ASD size, shape, location, and proximity to other structures.

Methods: Patients referred for possible transcatheter ASD closure underwent a comprehensive standard evaluation including transesophageal and/or intracardiac echocardiography (ICE), and invasive oximetry. CMR was performed in parallel and included direct en face veCMR after an optimal double-oblique imaging plane was determined accounting for ASD flow direction and cardiac-cycle interatrial septal motion.

We hypothesized that En face veCMR using an optimized imaging plane can accurately determine ASD flow, size, and morphology, and that it would provide information incremental to comprehensive standard evaluation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure

Exclusion Criteria:

  • Contraindications to magnetic resonance imaging
  • known sinus venosus or primum defects
  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): NCT00498446


Locations
United States, North Carolina
Duke Cardiovascular Magnetic Resonance Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Raymond J Kim, MD Duke Cardiovascular Magnetic Resonance Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00498446     History of Changes
Other Study ID Numbers: 3938
First Submitted: July 9, 2007
First Posted: July 10, 2007
Last Update Posted: June 19, 2013
Last Verified: July 2007

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