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| Name | Class |
|---|---|
| Feinstein Institute for Medical Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two consecutive 15-lead ECGs | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes |
| 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. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timmy Li, PhD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States | ||
| Long Island Jewish Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 30 minutes |
|
30 minutes
All adverse events (all cause mortality, serious-adverse, other - not serious) reported to P.I. in written form via data collection form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Original goal of 300 subjects was not reached. However, analysis of 295 subjects still yielded statistical valid results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research for Emergency Medicine | North Shore University Hospital | (516) 562-1513 | TLi2@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2018 | Feb 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The cardiologist will be blinded to the type of waveform they are analyzing (synthesized versus actual).
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| New Hyde Park |
| New York |
| 11040 |
| United States |
| ECGs not saved |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Number | 95% Confidence Interval | Kappa | 30 minutes |
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| 0 |
| 314 |
| 0 |
| 314 |
| 0 |
| 314 |
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| Title | Measurements |
|---|---|
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