Evaluation of Synthesized 18-Lead ECG in the Emergency Department

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03426436
Study type	Interventional
Source	Nihon Kohden
Contact
Status	Completed
Phase	N/A
Start date	February 14, 2018
Completion date	August 15, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.