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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Inter-rater variability for Standard 12-lead ECG readings [Time frame: 30 seconds]
• Inter-rater variability for AC 12L ECG readings [Time frame: 30 seconds]
• Number of standard 12-lead ECG readings requiring a consensus consultation [Time frame: 30 seconds]
• Number of AC 12L ECG readings requiring a consensus consultation [Time frame: 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]
• 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]
• 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]
• 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]
• Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 2 centers

• Mayo Clinic — Rochester
• Intermountain Health — Murray

United Kingdom · 2 centers

• Leeds General Infirmary — Leeds
• University of Edinburgh — Edinburgh

Publications

• Muhlestein JB, Anderson JL, Bethea CF, Severance HW, Mentz RJ, Barsness GW, Barbagelata A, Albert D, Le VT, Bunch TJ, Yanowitz F, May HT, Chisum B, Ronnow BS, Muhlestein JB; Duke University Cooperative Cardiovascular Society (DUCCS) investigators. Feasibility of combining serial smartphone single-lead electrocardiograms for the diagnosis of ST-elevation myocardial infarction. Am Heart J. 2020 Mar; PMID 31986289

Identifiers

NCT: NCT06271577 · PRO-0013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗