Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage (DOLOP)
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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. |
- 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.
- 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 |
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:
Patients will be excluded for meeting the contraindications for TEE or Optison administration.
- 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
- 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.
- Not able to provide informed consent
- 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| Contact: Brent D Wilson, MD, PHD | 8015852341 | brent.wilson@hsc.utah.edu |
| Contact: Christopher J McGann, MD | 8015852341 | chris.mcgann@hsc.utah.edu |
| 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 | |
| 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 June 17, 2013