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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Optison echocardiography contrast agent
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial fibrillation, stroke, TEE, Left atrial thrombus

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echo arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2012
Last Updated
August 17, 2019
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT01721447
Brief Title
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Acronym
DOLOP
Official Title
The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, stroke, TEE, Left atrial thrombus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echo arm
Arm Type
Experimental
Arm Description
Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent
Intervention Type
Drug
Intervention Name(s)
Optison echocardiography contrast agent
Other Intervention Name(s)
Perflutren Protein-Type A microspheres
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Confidence in Assessment of Left Atrial Appendage Thrombus
Description
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.
Time Frame
One Transesophageal Echocardiography, up to 1 hour
Secondary Outcome Measure Information:
Title
Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage
Description
Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent
Time Frame
One transesophageal echocardiography, up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent D Wilson, MD, PHD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18848430
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.
Results Reference
background
PubMed Identifier
10997346
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.
Results Reference
background
PubMed Identifier
18329848
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.
Results Reference
background
PubMed Identifier
10511659
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.
Results Reference
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Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage

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