CTRI/2025/08/092733尚未招募不适用
A Comparative Study of Contrast CT and Transesophageal Echocardiography for Left Atrial Appendage Thrombus Detection
nference Labs Private Limited1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The accuracy, sensitivity and specificity of Transesophageal Echocardiography (TEE) in detecting left atrial appendage (LAA) thrombus, evaluated against Contrast Cardiac CT as the reference standard
研究概览
简要总结
- This investigation is a prospective, blinded comparison study in which adult patients (more than 18 years) requiring evaluation for left atrial appendage (LAA) thrombus will undergo both Transesophageal Echocardiography (TEE) and Contrast Cardiac CT as per standard of care. Patients are enrolled following confirmation that they meet inclusion criteria, such as having atrial fibrillation and being suitable candidates for both TEE and CT. After informed consent is obtained, TEE is performed under routine clinical conditions. Subsequently, within a defined interval to minimize clinical changes, patients receive a Contrast Cardiac CT according to standardized cardiac imaging protocols. The TEE interpreter is blinded to the CT findings, while the CT images are evaluated by a separate cardiac imaging specialist unaware of TEE results.
- The primary endpoint is the accuracy, sensitivity and specificity of TEE in detecting LAA thrombus, using CT as the reference standard. The sole secondary endpoint included in this study is correlating the anatomical types and location of the left atrial appendage (LAA) identified by TEE with those observed on CT, thereby assessing the consistency of structural characterization between the two modalities. All relevant findings are captured in a secure database for subsequent statistical analysis, enabling a direct comparison of imaging results and a clear evaluation of TEE performance under rigorous, blinded conditions.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with atrial fibrillation or any other indications for LAA thrombus screening referred for routine Transesophageal echocardiogram and Contrast Computed Tomography.
排除标准
- 未提供
结局指标
主要结局
The accuracy, sensitivity and specificity of Transesophageal Echocardiography (TEE) in detecting left atrial appendage (LAA) thrombus, evaluated against Contrast Cardiac CT as the reference standard
时间窗: Only at baseline
次要结局
- Correlate anatomical types & location of left atrial appendage (LAA) identified by Transesophageal Echocardiography (TEE) in comparison with Contrast Cardiac CT as reference standard
研究者
Dr Satish Govind
Narayana Health
研究点 (1)
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