The Use of Optison Echocardiography Contrast in the Detection of Left Atrial Appendage Thrombus With Transesophageal Echocardiography.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent Confidence in Assessment of Left Atrial Appendage Thrombus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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.
排除标准
- •Contraindicated for Optison administration
- •Known right-to-left or bi-directional cardiac shunts
- •Hypersensitivity to perflutren, blood, blood products or albumen
- •Women who are pregnant
- •Removal of Left Atrial Appendage
- •Not able to provide informed consent
研究组 & 干预措施
Echo arm
Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent
干预措施: Optison echocardiography contrast agent (Drug)
结局指标
主要结局
Percent Confidence in Assessment of Left Atrial Appendage Thrombus
时间窗: One Transesophageal Echocardiography, up to 1 hour
Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.
次要结局
- Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage(One transesophageal echocardiography, up to 1 hour)
研究者
Brent Wilson
Assistant Professor of Internal Medicine
University of Utah