Postoperative Acute Myocardial Ischemic Injury

December 14, 2021 updated by: The Cleveland Clinic

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Noncardiac surgery
VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively
Device: VectraplexECG System with CEB®
The device will be used after noncardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: 1 minute to complete the test
Accuracy of VectraplexECG System with CEB
1 minute to complete the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Daniel Sessler, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

May 14, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1556

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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