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

NCT01721447 | Completed Phase 4 Results DMC

• 1 other identifier: 11-OPT-018 GE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; stroke; TEE; Left atrial thrombus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage

  One transesophageal echocardiography, up to 1 hour

Study Arms (1)

Echo arm

EXPERIMENTAL

Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent

Drug: Optison echocardiography contrast agent

Interventions

Optison echocardiography contrast agent DRUG

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.

Also known as: Perflutren Protein-Type A microspheres

Echo arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (4)

• 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.

  PMID: 18848430 BACKGROUND

• 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.

  PMID: 10997346 BACKGROUND

• 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.

  PMID: 18329848 BACKGROUND

• 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.

  PMID: 10511659 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Brent Wilson
• Organization: University of Utah Division of Cardiovascular Medicine

brent.wilson@hsc.utah.edu

801-585-2341

Study Officials

• Brent D Wilson, MD, PHD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: November 5, 2012
• Study Start: June 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 20, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-08

Locations

US (1)