NCT05649826招募中不适用
Optimization of an Ultrasound Cardiac Guidance Tool
UltraSight1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Acquisition of transthoracic echocardiography media from up to 200 subjects
研究概览
简要总结
This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed
详细描述
The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, aged 18 years and older
- •Subject willing and able to give written informed consent
排除标准
- •Emergency (non-elective) admission within 24 h prior to participating in the study
- •Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
- •Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
- •Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
- •Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
- •Subjects with BMI above
- •Subjects experiencing a known or suspected acute cardiac event.
- •Subjects with severe chest wall deformity as per previous medical records and physical examination.
- •Subjects who have undergone pneumonectomy.
- •Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).
结局指标
主要结局
Acquisition of transthoracic echocardiography media from up to 200 subjects
时间窗: up to 5 year
Several echocardiography views will be acquired from the participants, with in several acoustic windows and views
次要结局
未报告次要终点
研究者
研究点 (1)
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