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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

Page last updated: August 23, 2015

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