Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage (DOLOP)
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|ClinicalTrials.gov Identifier: NCT01721447|
Recruitment Status : Active, not recruiting
First Posted : November 5, 2012
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Optison echocardiography contrast agent||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||February 28, 2018|
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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721447
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Brent D Wilson, MD, PHD||University of Utah|