Clinical trial NCT06271577: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Ischemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Attack
Heart Failure
Lead sponsor: AliveCor
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


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.

Primary outcomes:
measure: Inter-rater variability for Standard 12-lead ECG readings
timeFrame: 30 seconds
measure: Inter-rater variability for AC 12L ECG readings
timeFrame: 30 seconds
measure: Number of standard 12-lead ECG readings requiring a consensus consultation
timeFrame: 30 seconds
measure: Number of AC 12L ECG readings requiring a consensus consultation
timeFrame: 30 seconds
measure: Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
timeFrame: 30 seconds
measure: Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
timeFrame: 30 seconds
measure: Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
timeFrame: 30 seconds
measure: 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
timeFrame: 30 seconds
measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI
timeFrame: 30 seconds
measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI
timeFrame: 30 seconds
measure: Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Murray
country: United States
facility: Intermountain Health
state: Utah
Study officials:
References:
citation: 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;221:125-135. doi: 10.1016/j.ahj.2019.12.016. Epub 2019 Dec 27.