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Completed

NCT Number: NCT01721447

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Perflutren Protein-Type A microspheres

Primary outcomes

  1. Percent Confidence in Assessment of Left Atrial Appendage Thrombus

    Time frame: One Transesophageal Echocardiography, up to 1 hour

    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 outcomes

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

    Time frame: One transesophageal echocardiography, up to 1 hour

    Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: DOLOP

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2012
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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