NCT07822581尚未招募不适用
"Discovery2" Study of Using Magnetocardiography (MCG) at Emergency Departments
SB Technology, Inc.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Training machine learning algorithms.
研究概览
简要总结
The purpose of this research is to collect the magnetic signals from the heart to identify features that may help Emergency Department (ED) doctors differentiate high and low risk patients for heart related chest pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men aged 22 years and older
- •Participant presenting with signs and symptoms suggestive of NSTE-ACS
- •In ED chest pain/NSTE-ACS care pathway
- •HEART Score 4+
- •Have received their first troponin result and can accommodate an MCG scan before the second troponin result.
排除标准
- •Unable to provide informed consent
- •ST elevation myocardial infarction (STEMI)
- •Active arrhythmia (as seen on the most recent ECG) such as atrial fibrillation, atrial flutter, ventricular tachycardia
- •Acute hemodynamic instability
- •Inability to lie supine and still for 5-10 minutes
- •Known or suspected pregnancy
- •Unable or unwilling to comply with required follow-up
- •Metallic passive implants that would make the participant unsuitable for MCG (e.g. spinal implants, metal shoulder replacements, dental implants.. etc.)
- •Active implantable medical devices (e.g. pacemakers, neurostimulators.. etc.)
- •Active illegal drug use per history of present illness
- •Contraindicated for temporary removal of telemetry during MCG scan
- •Clear non-ischemic cause for symptoms (e.g. trauma, viral infection, valve disease)
- •Clinical conditions that in the opinion of the Investigator would compromise the safety of the participant or ability to complete the protocol (e.g., exceeds bed weight limit, allergy to adhesives)
结局指标
主要结局
Training machine learning algorithms.
时间窗: Up to 30 Days
The main objective of the study is to collect MCG and other clinical data from the intended patient population for training machine learning algorithms to identify the presence of High Risk - Coronary Artery Disease (HRCAD).
次要结局
- Changes in MCG over time(Day 1)
研究者
研究点 (1)
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