Actively Recruiting
Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II
Led by AliveCor · Updated on 2026-04-09
1000
Participants Needed
4
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female older than 18 years of age
- Ability to understand and sign a written informed consent form before any study procedures
- Symptoms of chest pain when presenting at the Emergency Department of the participating institution
You will not qualify if you...
- Unable or unwilling to provide written informed consent for any reason
- Any condition that the Lead Investigator believes may increase risk to the participant or reduce the quality of the trial
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Intermountain Health
Murray, Utah, United States, 84107
Actively Recruiting
3
Leeds General Infirmary
Leeds, England, United Kingdom
Not Yet Recruiting
4
University of Edinburgh
Edinburgh, Scotland, United Kingdom
Not Yet Recruiting
Research Team
K
Kimberly Roohi, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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