Magnetic Resonance Imaging of Atrial Septal Defects

NCT ID: NCT00498446

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Septal Defect

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Principal Investigators

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Raymond J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Cardiovascular Magnetic Resonance Center

Locations

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Duke Cardiovascular Magnetic Resonance Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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. doi: 10.1161/CIRCIMAGING.108.769786.

Reference Type DERIVED
PMID: 19808512 (View on PubMed)

Other Identifiers

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3938

Identifier Type: -

Identifier Source: org_study_id

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