An Open Label Study for Determining the Optimal Cut-off Point of Peak Endocardial Acceleration Measured by Corsens Device for Discriminating Between MI and Non-MI Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety
研究概览
简要总结
Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted.
Corsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain.
- •Male or female subjects aged 18 years or more (with no upper limit), of any race.
- •Subjects willing to participate as evidenced by signing the written informed consent.
排除标准
- •Obese patients with BMI>
- •Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI.
- •Patients after coronary artery bypass grafting
- •Unstable hemodynamic condition.
- •Patient that can't or do not wish to sign the Inform Consent Form
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety
时间窗: 1 day
To verify the safety of the Corsens technology while use for myocardial infarction detection.
次要结局
- To define the optimal cut-off point (in terms of sensitivity and specificity) of the PEA measured by Corsens technology for discriminating between MI and non-MI patient.(12 months)