Postoperative Acute Myocardial Ischemic Injury

NCT02993263 | Terminated Results

• 1 other identifier: 15-1556
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Accuracy of VectraplexECG System with CEB

  1 minute to complete the test

Study Arms (1)

Noncardiac surgery

OTHER

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

Device: VectraplexECG System with CEB®

Interventions

VectraplexECG System with CEB® DEVICE

The device will be used after noncardiac surgery

Noncardiac surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• ≥ 45 years old.
• Anticipated hospitalization of at least two nights.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: Cleveland Clinic

sesslers@ccf.org

216-444-9400

Study Officials

• Daniel Sessler, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: December 15, 2016
• Study Start: February 1, 2016
• Primary Completion: May 14, 2018
• Study Completion: December 31, 2018
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (1)