Postoperative Acute Myocardial Ischemic Injury

Not Applicable

Terminated

• Conditions: Myocardial Infarction
• Interventions: Device: VectraplexECG System with CEB®

• Registration Number: NCT02993263
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-15
• Primary Completion: 2018-05-14
• Study Completion: 2018-12-31
• Results First Submitted: 2021-09-20
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Results First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 323

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Accuracy	1 minute to complete the test	Accuracy of VectraplexECG System with CEB

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States