Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage (DOLOP)
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| First Received Date ICMJE | October 25, 2012 | ||||||||
| Last Updated Date | November 1, 2012 | ||||||||
| Start Date ICMJE | December 2012 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01721447 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage | ||||||||
| Official Title ICMJE | The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography. | ||||||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Atrial Fibrillation | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: Echo arm
Subjects with atrial fibrillation who are undergoing a transesophageal echocardiography procedure for deciding treatment regimen
Intervention: Drug: Optison echocardiography contrast agent |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Patients will be excluded for meeting the contraindications for TEE or Optison administration.
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01721447 | ||||||||
| Other Study ID Numbers ICMJE | 11-OPT-018 GE | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Brent Wilson, University of Utah | ||||||||
| Study Sponsor ICMJE | University of Utah | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Utah | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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