Postoperative Acute Myocardial Ischemic Injury



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:3/9/2019
Start Date:February 2016
End Date:December 31, 2018

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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.


Inclusion Criteria:

1. Written informed consent.

2. ≥ 45 years old.

3. Anticipated hospitalization of at least two nights.

Exclusion Criteria:

1. Inadequate ECGs, based on an initial 10-second trace, as defined by:

- wandering baseline

- excessive noise

- ventricular ectopy

- pacer spikes or

- lead placement error

2. Atrial fibrillation.

3. Average heart rate exceeding 90 beats/minute.

4. 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
We found this trial at
1
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-9950
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