Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage

Atrial Fibrillation Clinical Trial

— DOLOP  

Official title:

The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721447
• Other study ID #: 11-OPT-018 GE
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: May 2018

Study information

• Verified date: August 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thrombosis

Intervention

Drug:
• Optison echocardiography contrast agent
Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. — View Citation

Clark LN, Dittrich HC. Cardiac imaging using Optison. Am J Cardiol. 2000 Aug 17;86(4A):14G-18G. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Confidence in Assessment of Left Atrial Appendage Thrombus	Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.	One Transesophageal Echocardiography, up to 1 hour
Secondary	Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage	Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent	One transesophageal echocardiography, up to 1 hour