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Postoperative Acute Myocardial Ischemic Injury

Primary Purpose

Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VectraplexECG System with CEB®
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Noncardiac surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy
Accuracy of VectraplexECG System with CEB

Secondary Outcome Measures

Full Information

First Posted
July 18, 2016
Last Updated
December 14, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02993263
Brief Title
Postoperative Acute Myocardial Ischemic Injury
Official Title
Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was withdrawn as there was an ECG equipment and software malfunction. There is no results for this study because of the equipment malfunction.
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 14, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noncardiac surgery
Arm Type
Other
Arm Description
VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively
Intervention Type
Device
Intervention Name(s)
VectraplexECG System with CEB®
Intervention Description
The device will be used after noncardiac surgery
Primary Outcome Measure Information:
Title
Accuracy
Description
Accuracy of VectraplexECG System with CEB
Time Frame
1 minute to complete the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sessler, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Postoperative Acute Myocardial Ischemic Injury

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