Evaluation of Synthesized 18-Lead ECG in the Emergency Department

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.