Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJune 22, 2010
August 1, 2009
2 years
November 24, 2008
June 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value)
24 hours
Study Arms (2)
1/Cases
Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE.
2/Controls
Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason.
Eligibility Criteria
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.
You may qualify if:
- atrial fibrillation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gundersen Lutheran Health System
La Crosse, Wisconsin, 54601, United States
Related Publications (9)
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.
PMID: 4180019BACKGROUNDHenry 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.
PMID: 128423BACKGROUNDStein 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.
PMID: 2199050BACKGROUNDPaydarfar 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.
PMID: 11385191BACKGROUNDBarkhausen 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.
PMID: 12438051BACKGROUNDOhyama 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.
PMID: 12181211BACKGROUNDOhyama 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.
PMID: 12970519BACKGROUNDMohrs 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.
PMID: 16357402BACKGROUNDSaksena 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raju G Ailiani, MD
Gundersen Lutheran Health System
- STUDY DIRECTOR
Vicki L McHugh, MS
Gundersen Lutheran Medical Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
June 22, 2010
Record last verified: 2009-08