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NCT03426436 · ClinicalTrials.gov registry record · NA
Evaluation of Synthesized 18-Lead ECG in the Emergency Department
A NA study of Chest Pain, sponsored by Nihon Kohden.
- Completed
- Registry status
- NA
- Development phase
- 314
- Enrollment target
- 2
- Study locations
NCT03426436: Completed NA study of Chest Pain, sponsored by Nihon Kohden.
NCT03426436 is a NA study of Chest Pain that has completed, run by Nihon Kohden. The registered enrollment target is 314 participants, below the 1,444-participant average among 22 other Chest Pain trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03426436, a NA study of Chest Pain, has completed, sponsored by Nihon Kohden.
- COMPLETED
- Registry status
- NA
- Development phase
- 314 participants
- Enrollment target
- 2
- Study locations
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
Primary Outcome
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.
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 |
What the finished NCT03426436 record still lists
NCT03426436 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 1,444-participant average among 22 other Chest Pain trials with a reported enrollment target (78% lower).
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.
NCT03426436 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT03426436?
The interventions under investigation include: Two consecutive 15-lead ECGs (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03426436?
This trial is sponsored by Nihon Kohden, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03426436's enrollment target sits among peer trials
314 13th of 22 higher than 10 of 22 other Chest Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chest Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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