Postoperative Acute Myocardial Ischemic Injury
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Written informed consent.
- ≥ 45 years old.
- Anticipated hospitalization of at least two nights.
Exclusion criteria
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Inadequate ECGs, based on an initial 10-second trace, as defined by:
- wandering baseline
- excessive noise
- ventricular ectopy
- pacer spikes or
- lead placement error
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Atrial fibrillation.
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Average heart rate exceeding 90 beats/minute.
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
323 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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