Postoperative Acute Myocardial Ischemic Injury

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Noncardiac surgery

VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively

Group Type OTHER

VectraplexECG System with CEB®

Intervention Type DEVICE

The device will be used after noncardiac surgery

Interventions

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VectraplexECG System with CEB®

The device will be used after noncardiac surgery

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No