Chest Pain
Conditions
Brief summary
This study, sponsored by Nihon Kohden, aims to determine the sensitivity and specificity of synthesized 18-lead electrocardiogram (ECG) in the diagnosis of posterior-lateral and/or right-ventricular ischemia, using actual 18-lead ECG as the gold standard. The synthesized 18-lead ECG calculates six extra leads of information from the standard 12-lead ECG done in the Emergency Department (ED). Nihon Kohden has created synECi18 Technology, which can mathematically synthesize and display the extra leads. The patient population (n=300) will consist of patients who present to the North Shore University Hospital or Long Island Jewish Medical Center ED with a chief complaint of chest pain, chest pressure, or chest discomfort. These patients will be receiving a standard 12-lead ECG as part of their routine clinical care. Patients with ST-Elevation Myocardial Infarction (STEMI) and a known positive troponin value will be excluded from the study. Trained ED study technicians will use ECG machines provided by Nihon Kohden to obtain two consecutive 15-lead ECGs. The two 15-lead ECGs are then saved onto the ECG machine.The saved information will later be input into an algorithm to calculate the synthesized 18-leads. The actual 18-leads (composed of the two 15-leads conducted in the ED) will be compared with the synthesized 18-leads produced by the synECi18 technology. A study cardiologists will evaluate the actual 18-lead ECGs and synthesized 18-lead ECGs and determine whether there is posterior-lateral and/or right-sided ventricular ischemia. The cardiologists will be blinded to the type of waveform they are analyzing (synthesized versus actual). The study will not interfere with patient care or treatment, however, the two 15-lead ECGs done in the ED will be shown to the physician who can determine whether or not to order an official 18-lead ECG in the hospital's electronic medical record system. It is hypothesized that the synECi18 synthesized 18-lead ECGs will provide high sensitivity and specificity for diagnosing posterior-lateral and/or right-ventricular ischemia, with the actual 18-lead ECGs being used as the reference for comparison.
Interventions
DIAGNOSTIC_TESTTwo consecutive 15-lead ECGs
The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Sponsors
Feinstein Institute for Medical Research
Nihon Kohden
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The cardiologist will be blinded to the type of waveform they are analyzing (synthesized versus actual).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a chief complaint of chest pain or chest discomfort or chest pressure * Troponin test has been ordered (unknown positive at time of recruitment) * Subjects are capable of providing informed consent * English speaking
Exclusion criteria
* STEMI patients * Patients who have not had a troponin test ordered * Pregnant women * Patients under 18 years of age * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | 30 minutes | Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index. |
| Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | 30 minutes | Kappa value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side. | 295 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consent issue | 1 |
| Overall Study | ECGs not saved | 4 |
| Overall Study | Incorrect lead placement | 12 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Test | — |
|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 295 participants | — |
| Sex: Female, Male Female | 150 Participants | — |
| Sex: Female, Male Male | 145 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 314 |
| other Total, other adverse events | 0 / 314 |
| serious Total, serious adverse events | 0 / 314 |
Outcome results
Primary
Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
Kappa value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.
Time frame: 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Elevation | 1.00 Kappa |
| All Participants | Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Depression | 1.00 Kappa |
| All Participants | Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | T Wave Inversion | 0.70 Kappa |
Primary
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.
Time frame: 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Elevation Sensitivity | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Elevation Specificity | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Elevation PPV | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Elevation NPV | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Depression Sensitivity | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Depression Specificity | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Depression PPV | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | ST Depression NPV | 100 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | T Wave Inversion Sensitivity | 95 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | T Wave Inversion Specificity | 80 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | T Wave Inversion PPV | 97 percentage of participants |
| All Participants | Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion | T Wave Inversion NPV | 70 percentage of participants |