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NCT Number: NCT06271577

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Attack Heart Diseases Heart Failure Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds General Infirmary, Leeds, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AliveCor 12-lead ECG

Device

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 outcomes

  1. Inter-rater variability for Standard 12-lead ECG readings

    Time frame: 30 seconds

  2. Inter-rater variability for AC 12L ECG readings

    Time frame: 30 seconds

  3. Number of standard 12-lead ECG readings requiring a consensus consultation

    Time frame: 30 seconds

  4. Number of AC 12L ECG readings requiring a consensus consultation

    Time frame: 30 seconds

  5. 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

  6. 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

  7. 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

  8. 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

  9. Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI

    Time frame: 30 seconds

  10. Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI

    Time frame: 30 seconds

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Roohi, MS

CONTACT

[email protected]

855-338-8800

Sponsors and collaborators

Lead sponsor

AliveCor

Industry

Registry information

Official study title

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

Acronym: STLEUISII

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 22, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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