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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01721447
Recruitment Status : Active, not recruiting
First Posted : November 5, 2012
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):

October 25, 2012
November 5, 2012
November 21, 2017
June 2013
February 28, 2018   (Final data collection date for primary outcome measure)
Sensitivity of TEE to identify thrombus in left atrium [ Time Frame: one Transesophageal Echocardiography ]
We will be assessing the sensitivity and specificity of TEE to identify thrombus (blood clot) in the left atrial appendage.
Same as current
Complete list of historical versions of study NCT01721447 on ClinicalTrials.gov Archive Site
Specificity of TEE to detect left atrial thrombus [ Time Frame: One transesophageal echocardiography ]
The investigators will test the specificity of ability of optison to detecting left atrial thrombus during transesophageal echocardiography
Same as current
Not Provided
Not Provided
 
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.
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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Atrial Fibrillation
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
Experimental: Echo arm
Subjects with atrial fibrillation who are undergoing a transesophageal echocardiography procedure for deciding treatment regimen
Intervention: Drug: Optison echocardiography contrast agent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
February 28, 2018
February 28, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01721447
11-OPT-018 GE
Yes
Not Provided
Not Provided
Brent Wilson, University of Utah
University of Utah
Not Provided
Principal Investigator: Brent D Wilson, MD, PHD University of Utah
University of Utah
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP