NCT02993263

Postoperative Acute Myocardial Ischemic Injury

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	VectraplexECG System with CEB®	The device will be used after noncardiac surgery

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-05-14
• Completion: 2018-12-31
• First posted: 2016-12-15
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

1 site across 1 country: United States