NCT06620744已完成不适用
Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin
SB Technology, Inc.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.
研究概览
简要总结
This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)
排除标准
- •Present STEMI
- •Having an active atrial fibrillation episode as seen on 12-lead ECG
- •Clear non-ischemic cause for symptoms (e.g. trauma)
- •Active thoracic metal implants
结局指标
主要结局
Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.
时间窗: Per-scan, on average 5 minutes, day of enrollment
MCG Data Quality
次要结局
- Sandbox MCG safety(30-days)
研究者
研究点 (2)
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