Postoperative Acute Myocardial Ischemic Injury
Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Written informed consent.
- ≥ 45 years old.
- Anticipated hospitalization of at least two nights.
Exclusion Criteria:
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Noncardiac surgery
VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively
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The device will be used after noncardiac surgery
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Accuracy
大体时间:1 minute to complete the test
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Accuracy of VectraplexECG System with CEB
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1 minute to complete the test
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合作者和调查者
调查人员
- 首席研究员:Daniel Sessler, M.D.、The Cleveland Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
VectraplexECG System with CEB®的临床试验
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Archus Orthopedics, Inc.未知腰背疼痛 | 脊柱疾病 | 腰椎管狭窄症 | 椎管狭窄 | 腰椎滑脱 | 腿痛
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Abiomed Inc.招聘中