Clinical trial NCT01721447: Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Official title: The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
stroke
TEE
Left atrial thrombus
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo contrast.

Detailed description: Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation) and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial fibrillation ablation procedures at a time when there is higher risk of subsequent embolic stroke.

Several of the patients with atrial fibrillation require transesophageal echocardiography (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is opportunity to enroll most of these patients in our proposed study. There has been essentially no work published about the use of echo contrast materials in TEE (other than agitated saline), particularly the use of Optison. Thus, the investigators will be exploring a new field in echocardiography and echo contrast.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Cognitively sound and able to provide informed consent
* Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion Criteria:

* Contraindicated for Optison administration
* Known right-to-left or bi-directional cardiac shunts
* Hypersensitivity to perflutren, blood, blood products or albumen
* Women who are pregnant
* Removal of Left Atrial Appendage
* Not able to provide informed consent

Primary outcomes:
measure: Percent Confidence in Assessment of Left Atrial Appendage Thrombus
timeFrame: One Transesophageal Echocardiography, up to 1 hour
Secondary outcomes:
measure: Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage
timeFrame: One transesophageal echocardiography, up to 1 hour
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Brent D Wilson, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei K, Mulvagh SL, Carson L, Davidoff R, Gabriel R, Grimm RA, Wilson S, Fane L, Herzog CA, Zoghbi WA, Taylor R, Farrar M, Chaudhry FA, Porter TR, Irani W, Lang RM. The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. J Am Soc Echocardiogr. 2008 Nov;21(11):1202-6. doi: 10.1016/j.echo.2008.07.019. Epub 2008 Oct 10.
citation: Clark LN, Dittrich HC. Cardiac imaging using Optison. Am J Cardiol. 2000 Aug 17;86(4A):14G-18G. doi: 10.1016/s0002-9149(00)00984-x.
citation: Bhatia VK, Senior R. Contrast echocardiography: evidence for clinical use. J Am Soc Echocardiogr. 2008 May;21(5):409-16. doi: 10.1016/j.echo.2008.01.018. Epub 2008 Mar 10.
citation: Bednarz JE, Spencer KT, Weinert L, Sugeng L, Mor-Avi V, Lang RM. Identification of cardiac masses and abnormal blood flow patterns with harmonic power Doppler contrast echocardiography. J Am Soc Echocardiogr. 1999 Oct;12(10):871-5. doi: 10.1016/s0894-7317(99)70195-1.