Clinical trial NCT00797576: Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
Official title: Detection of Left Atrial Appendage Thrombus in Patients Referred For Cardioversion: Comparative Analysis of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Atrial Appendage Thrombi
Keywords: left atrial appendage thrombi
transesophageal echocardiogram
cardiac magnetic resonance imaging
atrial fibrillation
cardioversion
Lead sponsor: Gundersen Lutheran Medical Foundation
Sponsor class: OTHER
Collaborators: name: Gundersen Lutheran Health System
First posted: 2008-11-25
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cases will consist of subjects referred for TEE prior to cardioversion who are found to have LAA thrombus present. Control subjects will be patients referred for TEE with chronic atrial fibrillation that will not be undergoing cardioversion. All subjects will be patients from our facility, Gundersen Lutheran Health System, La Crosse, WI.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Gundersen Lutheran Health System
state: Wisconsin
Study officials:
affiliation: Gundersen Lutheran Health System
name: Raju G Ailiani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gundersen Lutheran Medical Foundation
name: Vicki L McHugh, MS
role: STUDY_DIRECTOR
References:
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citation: 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.
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citation: 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.
citation: 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.