Evaluation of Synthesized 18-Lead ECG in the Emergency Department

NCT03426436 | Completed Results FDA Device

• 1 other identifier: 17-0936
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Diagnostic Test: Two consecutive 15-lead ECGs

Interventions

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.

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a chief complaint of chest pain or chest discomfort or chest pressure
• Troponin test has been ordered (unknown positive at time of recruitment)
• Subjects are capable of providing informed consent
• English speaking

You may not qualify if:

• STEMI patients
• Patients who have not had a troponin test ordered
• Pregnant women
• Patients under 18 years of age
• Prisoners

Sponsors & Collaborators

• Nihon Kohden: lead
• Feinstein Institute for Medical Research: collaborator

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Original goal of 300 subjects was not reached. However, analysis of 295 subjects still yielded statistical valid results.

Results Point of Contact

• Title: Director of Clinical Research for Emergency Medicine
• Organization: North Shore University Hospital

TLi2@northwell.edu

(516) 562-1513

Study Officials

• Timmy Li, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The cardiologist will be blinded to the type of waveform they are analyzing (synthesized versus actual).
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 8, 2018
• Study Start: February 14, 2018
• Primary Completion: August 16, 2018
• Study Completion: August 15, 2019
• Last Updated: November 25, 2019
• Results First Posted: November 25, 2019

Record last verified: 2019-10

Locations

US (2)