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Evaluation of Synthesized 18-Lead ECG in the Emergency Department
NCT03426436 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Two consecutive 15-lead ECGs
Study Locations (2)
New York
- North Shore University Hospital — Manhasset
- Long Island Jewish Medical Center — New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2018-02-14 |
| Est. Completion | 2019-08-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03426436
The ClinicalTrials.gov registry entry for NCT03426436 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nihon Kohden, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chest Pain appearing as the primary indexed condition, and to 1 intervention — of which Two consecutive 15-lead ECGs is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03426436 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03426436 about?
NCT03426436 is a clinical study titled "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 e...
What is the current status of trial NCT03426436?
This trial is currently completed. It is a NA study. The enrollment target is 314 participants. The study started on 2018-02-14. Estimated completion is 2019-08-15.
What conditions does trial NCT03426436 study?
This clinical trial studies the following conditions: Chest Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03426436?
The interventions under investigation include: Two consecutive 15-lead ECGs (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03426436?
This trial is sponsored by Nihon Kohden, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03426436 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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