Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (STLEUISII)

March 18, 2024 updated by: AliveCor

Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (STLEUISII)

AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).

Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gregory Barsness, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female > 18 years of age.
  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
  • Symptoms of chest pain upon presentation at the Emergency Department of the participating institution.

Exclusion Criteria:

  • Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
  • Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AliveCor 12-lead ECG
A single research-related procedure will be required (i.e., an AliveCor 12-lead ECG). Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires.
Device: AliveCor 12-lead ECG
The primary objective of this study is to determine if the AliveCor 12-lead Smartphone ECG is an acceptable substitute for a standard 12-lead ECG in the identification of STEMI and NSTEMI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inter-rater variability for Standard 12-lead ECG readings
Time Frame: 30 seconds
30 seconds
Inter-rater variability for AC 12L ECG readings
Time Frame: 30 seconds
30 seconds
Number of standard 12-lead ECG readings requiring a consensus consultation
Time Frame: 30 seconds
30 seconds
Number of AC 12L ECG readings requiring a consensus consultation
Time Frame: 30 seconds
30 seconds
Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time Frame: 30 seconds
30 seconds
Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time Frame: 30 seconds
30 seconds
Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time Frame: 30 seconds
30 seconds
Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time Frame: 30 seconds
30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI
Time Frame: 30 seconds
30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI
Time Frame: 30 seconds
30 seconds
Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs
Time Frame: 30 seconds
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AliveCor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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