Magnetic Resonance Imaging of Atrial Septal Defects
| Tracking Information | |||||
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| First Received Date ICMJE | July 9, 2007 | ||||
| Last Updated Date | July 9, 2007 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Magnetic Resonance Imaging of Atrial Septal Defects | ||||
| Official Title ICMJE | Imaging of Atrial Septal Defects by Velocity Encoded Cardiovascular Magnetic Resonance | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Atrial Septal Defect | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Thomson LE, Crowley AL, Heitner JF, Cawley PJ, Weinsaft JW, Kim HW, Parker M, Judd RM, Harrison JK, Kim RJ. Direct en face imaging of secundum atrial septal defects by velocity-encoded cardiovascular magnetic resonance in patients evaluated for possible transcatheter closure. Circ Cardiovasc Imaging. 2008 Jul;1(1):31-40. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 44 | ||||
| Completion Date | July 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00498446 | ||||
| Other Study ID Numbers ICMJE | ASD3938-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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