NCT06095557已完成不适用
Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)
SB Technology, Inc.1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年10月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- % analyzable Sandbox MCG data
研究概览
简要总结
This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
- •Can provide written consent
排除标准
- •Presents to ED with ST-Elevation Myocardial Infarction (STEMI)
- •Presents to ED with Atrial Fibrillation
- •Clear non-ischemic cause for symptoms (i.e. trauma)
- •Active thoracic metal implants
研究组 & 干预措施
Sponsor MCG device
Experimental
All participants will receive a scan from the Sponsor MCG device
干预措施: Sponsor MCG device (Device)
结局指标
主要结局
% analyzable Sandbox MCG data
时间窗: during the procedure (MCG scan)
% Sandbox MCG data collected and suitable for analysis
次要结局
- Characterization of scan results that may differentiate between high risk and low risk ACS patients(during the procedure (MCG scan))
- Sandbox MCG safety(30 days)
研究者
研究点 (1)
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