Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram

NCT ID: NCT00797576

Last Updated: 2010-06-22

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

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.

Detailed Description

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The identification of left atrial appendage (LAA) thrombus prior to cardioversion for patients with atrial fibrillation is crucial. LAA thrombus can be a frequent cause of cerebral stroke or peripheral embolism post cardioversion, and anticoagulation therapy is required in these instances to prevent cerebral events and avoid embolization. To date, TEE has been considered the clinical reference in detection of LAA thrombi with high diagnostic accuracy. However, diagnosis and size estimation of LAA thrombi remains challenging due to the complex anatomy of the LAA, and transesophageal echocardiography (TEE) is considered a semi-invasive procedure. To date, there have been few comparative studies involving TEE and cardiac magnetic resonance (CMR) imaging, and the results have been conflicting. With newer CMR Imaging techniques now available, we hypothesize that comparable results will be achieved in detecting LAA thrombus in subjects using a less invasive procedure.

Conditions

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Left Atrial Appendage Thrombi

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1/Cases

Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE.

No interventions assigned to this group

2/Controls

Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* atrial fibrillation

Exclusion Criteria

* ICDs
* pacemakers
* intracranial clips
* intracranial stimulator devices
* insulin pumps
* intra ocular metal foreign bodies
* cochlear implants
* LAA amputation as part of CABG and/or valve surgery
* GFR \< 60 mL/min
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gundersen Lutheran Health System

OTHER

Sponsor Role collaborator

Gundersen Lutheran Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Gundersen Lutheran Helath system

Principal Investigators

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Raju G Ailiani, MD

Role: PRINCIPAL_INVESTIGATOR

Gundersen Lutheran Health System

Vicki L McHugh, MS

Role: STUDY_DIRECTOR

Gundersen Lutheran Medical Foundation

Locations

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Gundersen Lutheran Health System

La Crosse, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Raju G Ailiani, MD

Role: CONTACT

608-775-2595

Facility Contacts

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Vicki L McHugh, MS

Role: primary

608-775-3857

Kara J Kallies, BA

Role: backup

608-775-2904

References

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Bjerkelund CJ, Orning OM. The efficacy of anticoagulant therapy in preventing embolism related to D.C. electrical conversion of atrial fibrillation. Am J Cardiol. 1969 Feb;23(2):208-16. doi: 10.1016/0002-9149(69)90068-x. No abstract available.

Reference Type BACKGROUND
PMID: 4180019 (View on PubMed)

Henry WL, Morganroth J, Pearlman AS, Clark CE, Redwood DR, Itscoitz SB, Epstein SE. Relation between echocardiographically determined left atrial size and atrial fibrillation. Circulation. 1976 Feb;53(2):273-9. doi: 10.1161/01.cir.53.2.273.

Reference Type BACKGROUND
PMID: 128423 (View on PubMed)

Stein B, Halperin JL, Fuster V. Should patients with atrial fibrillation be anticoagulated prior to and chronically following cardioversion? Cardiovasc Clin. 1990;21(1):231-47; discussion 248-9. No abstract available.

Reference Type BACKGROUND
PMID: 2199050 (View on PubMed)

Paydarfar D, Krieger D, Dib N, Blair RH, Pastore JO, Stetz JJ Jr, Symes JF. In vivo magnetic resonance imaging and surgical histopathology of intracardiac masses: distinct features of subacute thrombi. Cardiology. 2001;95(1):40-7. doi: 10.1159/000047342.

Reference Type BACKGROUND
PMID: 11385191 (View on PubMed)

Barkhausen J, Hunold P, Eggebrecht H, Schuler WO, Sabin GV, Erbel R, Debatin JF. Detection and characterization of intracardiac thrombi on MR imaging. AJR Am J Roentgenol. 2002 Dec;179(6):1539-44. doi: 10.2214/ajr.179.6.1791539.

Reference Type BACKGROUND
PMID: 12438051 (View on PubMed)

Ohyama H, Mizushige K, Hosomi N. Magnetic resonance imaging of left atrial thrombus. Heart. 2002 Sep;88(3):233. doi: 10.1136/heart.88.3.233. No abstract available.

Reference Type BACKGROUND
PMID: 12181211 (View on PubMed)

Ohyama H, Hosomi N, Takahashi T, Mizushige K, Osaka K, Kohno M, Koziol JA. Comparison of magnetic resonance imaging and transesophageal echocardiography in detection of thrombus in the left atrial appendage. Stroke. 2003 Oct;34(10):2436-9. doi: 10.1161/01.STR.0000090350.73614.0F. Epub 2003 Sep 11.

Reference Type BACKGROUND
PMID: 12970519 (View on PubMed)

Mohrs OK, Nowak B, Petersen SE, Welsner M, Rubel C, Magedanz A, Kauczor HU, Voigtlaender T. Thrombus detection in the left atrial appendage using contrast-enhanced MRI: a pilot study. AJR Am J Roentgenol. 2006 Jan;186(1):198-205. doi: 10.2214/AJR.04.1504.

Reference Type BACKGROUND
PMID: 16357402 (View on PubMed)

Saksena S, Sra JS, Jordaens L, et al. Intracardiac Echocardiography-Guided Cardioversion Helps Interventional Procedures (ICE-CHIP) trial. Heart Rhythm Society 2007 Scientific Sessions; May 11, 2007; Denver, CO. Late Breaking clinical Trials II.

Reference Type BACKGROUND

Other Identifiers

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2-07-05-001

Identifier Type: -

Identifier Source: org_study_id

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