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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Brent Wilson, University of Utah
ClinicalTrials.gov Identifier:
NCT01721447
First received: October 25, 2012
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Optison echocardiography contrast agent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Sensitivity of TEE to identify thrombus in left atrium [ Time Frame: one Transesophageal Echocardiography ] [ Designated as safety issue: No ]
    We will be assessing the sensitivity and specificity of TEE to identify thrombus (blood clot) in the left atrial appendage.


Secondary Outcome Measures:
  • Specificity of TEE to detect left atrial thrombus [ Time Frame: One transesophageal echocardiography ] [ Designated as safety issue: No ]
    The investigators will test the specificity of ability of optison to detecting left atrial thrombus during transesophageal echocardiography


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Echo arm
Subjects with atrial fibrillation who are undergoing a transesophageal echocardiography procedure for deciding treatment regimen
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.
Other Name: Perflutren Protein-Type A microspheres

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. > 18 years old
  2. Cognitively sound and able to provide informed consent
  3. Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion Criteria:

Patients will be excluded for meeting the contraindications for TEE or Optison administration.

  1. Contraindications for TEE: Esophageal stricture, tracheoesophageal fistula, postesophageal surgery, esophageal trauma, esophagectomy/esophagogastrectomy, barrett esophagus, hiatal hernia, large descending aortic aneurysm, unilateral vocal cord paralysis, esophageal varices, postradiation therapy, previous bariatric surgery, zenker diverticulum, colonic interposition, dysphagia
  2. Contraindications for administration of Optison, including but not limited to: Right-to-left cardiovascular shunt, bidirectional cardiovascular shunt, history of myocardial infarction, acute coronary syndrome, pulmonary embolism, pulmonary hypertension, tachycardia, Torsades de Pointes, prolonged Q-T Interval, acute heart failure, vasculitis, emphysema, respiratory compromise, congenital heart disease, hypoxia, allergy to albumin; Individuals objecting to receiving albumin, a blood product, for personal, religious, or cultural reasons.
  3. Not able to provide informed consent
  4. Women who are or who may become pregnant (since Optison may have effects on the fetus that are currently unknown). Women who show evidence for practicing approved contraceptive measure (abstinence, male or female condoms, on contraceptive pills, injection, ring or having mechanical devices such as Intra Uterine Devices) will be allowed to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721447

Contacts
Contact: Brent D Wilson, MD, PHD 8015852341 brent.wilson@hsc.utah.edu
Contact: Christopher J McGann, MD 8015852341 chris.mcgann@hsc.utah.edu

Locations
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Brent D Wilson, MD, PHD    801-581-2341    brent.wilson@hsc.utah.edu   
Contact: Christopher J McGann, MD    8015812341    chris.mcgann@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Brent D Wilson, MD, PHD University of Utah
  More Information

Publications:
Responsible Party: Brent Wilson, Assistant Professor of Internal Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT01721447     History of Changes
Other Study ID Numbers: 11-OPT-018 GE
Study First Received: October 25, 2012
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Atrial fibrillation
stroke
TEE
Left atrial thrombus

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014