Myocardial Infarction
Conditions
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.
Interventions
DEVICEVectraplexECG System with CEB®
The device will be used after noncardiac surgery
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | 1 minute to complete the test | Accuracy of VectraplexECG System with CEB |
Countries
United States
Participant flow
Recruitment details
Recruitment process started by screening patients who are scheduled for non cardiac surgery. These patients are approached during their anesthesia clearance visit.
Pre-assignment details
Open label study
Participants by arm
| Arm | Count |
|---|---|
| Noncardiac Surgery VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively | 323 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment Software failed and results were lost. | 323 |
Baseline characteristics
| Characteristic | Noncardiac Surgery | — |
|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 9.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 164 Participants | — |
| Sex: Female, Male Male | 159 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Accuracy
Accuracy of VectraplexECG System with CEB
Time frame: 1 minute to complete the test
Population: Data were not collected, because of the malfunction of the equipment software failed.