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

University of Utah100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Atrial Fibrillation

Interventions

Optison echocardiography contrast agentDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: One Transesophageal Echocardiography, up to 1 hour

Secondary Outcomes

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

Time frame: One transesophageal echocardiography, up to 1 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.