Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Identification of Active Myocardial Ischemia
研究概览
简要总结
Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia.
This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI).
Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.
排除标准
- •≤ 18 years of age
- •Patients unable to fit into device
- •Non-ambulatory patients
- •Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax)
- •Patients with claustrophobia
- •Pregnant women
- •Poor candidate for follow-up
- •Repeat participants
结局指标
主要结局
Identification of Active Myocardial Ischemia
时间窗: 1 week
Comparison of Magnetocardiography (MCG) and imaging of magnetic field/current will be directly compared to cardiac catheterization data in those patients who undergo this procedure.
次要结局
- Medium term Adverse Cardiac Events(6 months)