Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
The investigators propose to estimate the sensitivity and specificity of the VectraplexECG System for detecting acute myocardial ischemic injury, including acute myocardial infarctions after major non-cardiac surgery.
A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the post-anesthesia care unit.
On the first, second and third post operative morning a 10 second CEB dynamic sequence will be recorded. Blood will be sampled for troponin as well.
On the first, second and third post operative afternoons a 10 second CEB dynamic sequence will be recorded.
The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will continue as long as the patient remains hospitalized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •≥ 45 years old.
- •Anticipated hospitalization of at least two nights.
排除标准
- •Inadequate ECGs, based on an initial 10-second trace, as defined by:
- •wandering baseline
- •excessive noise
- •ventricular ectopy
- •pacer spikes or
- •lead placement error
- •Atrial fibrillation.
- •Average heart rate exceeding 90 beats/minute.
- •Evidence of previous myocardial infarction:
- •Pathologic Q waves (≥0.04 sec) and/or
- •Pathologic findings of a healed or healing MI and/or
- •Evidence from an imaging study of a region of loss of viable myocardium
研究组 & 干预措施
Noncardiac surgery
VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively
干预措施: VectraplexECG System with CEB® (Device)
结局指标
主要结局
Accuracy
时间窗: 1 minute to complete the test
Accuracy of VectraplexECG System with CEB
次要结局
未报告次要终点