Postoperative Acute Myocardial Ischemic Injury

Myocardial Infarction Clinical Trial

Official title:

Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02993263
• Other study ID #: 15-1556
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 323
• Est. completion date: December 31, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• VectraplexECG System with CEB®
The device will be used after noncardiac surgery

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Accuracy of VectraplexECG System with CEB	1 minute to complete the test