Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Optison echocardiography contrast agent (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s): Brent D Wilson, MD, PHD, Principal Investigator, Affiliation: University of Utah
Overall contact: Brent D Wilson, MD, PHD, Phone: 8015852341, Email: brent.wilson@hsc.utah.edu
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.
Clinical Details
Official title: The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Sensitivity of TEE to identify thrombus in left atrium
Secondary outcome: Specificity of TEE to detect left atrial thrombus
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. > 18 years old
2. Cognitively sound and able to provide informed consent
3. Indicated for TEE as a standard clinical procedure for evaluation of cardiac health
status.
Exclusion Criteria:
Patients will be excluded for meeting the contraindications for TEE or Optison
administration.
1. Contraindications for TEE: Esophageal stricture, tracheoesophageal fistula,
postesophageal surgery, esophageal trauma, esophagectomy/esophagogastrectomy, barrett
esophagus, hiatal hernia, large descending aortic aneurysm, unilateral vocal cord
paralysis, esophageal varices, postradiation therapy, previous bariatric surgery,
zenker diverticulum, colonic interposition, dysphagia
2. Contraindications for administration of Optison, including but not limited to:
Right-to-left cardiovascular shunt, bidirectional cardiovascular shunt, history of
myocardial infarction, acute coronary syndrome, pulmonary embolism, pulmonary
hypertension, tachycardia, Torsades de Pointes, prolonged Q-T Interval, acute heart
failure, vasculitis, emphysema, respiratory compromise, congenital heart disease,
hypoxia, allergy to albumin; Individuals objecting to receiving albumin, a blood
product, for personal, religious, or cultural reasons.
3. Not able to provide informed consent
4. Women who are or who may become pregnant (since Optison may have effects on the fetus
that are currently unknown). Women who show evidence for practicing approved
contraceptive measure (abstinence, male or female condoms, on contraceptive pills,
injection, ring or having mechanical devices such as Intra Uterine Devices) will be
allowed to participate.
Locations and Contacts
Brent D Wilson, MD, PHD, Phone: 8015852341, Email: brent.wilson@hsc.utah.edu
University of Utah, Salt Lake City, Utah 84132, United States; Not yet recruiting Brent D Wilson, MD, PHD, Phone: 801-581-2341, Email: brent.wilson@hsc.utah.edu Christopher J McGann, MD, Phone: 8015812341, Email: chris.mcgann@hsc.utah.edu
Additional Information
Related publications: 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. Clark LN, Dittrich HC. Cardiac imaging using Optison. Am J Cardiol. 2000 Aug 17;86(4A):14G-18G. Review. 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. Review. 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.
Starting date: December 2012
Last updated: November 1, 2012
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