Using a smartphone device to record 12-lead ECGs for heart attack diagnosis
Official title: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (STLEUISII)
Run by AliveCor · NCT06271577 · Data updated 2026-11-12
This study is testing a smartphone device that records heart activity to see if it can help doctors quickly diagnose heart attacks in adults who come to the emergency room with chest pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | AliveCor Industry-sponsored |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Status | Recruiting |
| Started | March 12, 2024 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT06271577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who present with symptoms of chest pain at participating emergency departments.
✕Probably not a fit
Patients who are unable or unwilling to provide informed consent or have conditions that may increase their risk during the trial may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the AliveCor 12-lead ECG System, which can record multiple leads of ECG simultaneously, in diagnosing ST-Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI). Participants will be adults presenting with chest pain at emergency departments, where the device's performance will be compared to standard ECG methods. The study aims to validate the accuracy of this innovative technology in a clinical setting, potentially improving rapid diagnosis and treatment of heart conditions.
Why it matters
Potential benefit: If successful, this technology could enable faster and more accurate diagnosis of heart attacks, leading to timely treatment and improved patient outcomes.
How similar studies have gone: Previous studies, such as the ST LEUIS study, have shown success in validating similar ECG devices for diagnosing myocardial infarctions.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
Intermountain Health
Murray, Utah, United States Recruiting -
Leeds General Infirmary
Leeds, England, United Kingdom Not yet recruiting -
University of Edinburgh
Edinburgh, Scotland, United Kingdom Not yet recruiting
Study contacts
- Study coordinator: Kimberly Roohi, MS
- Email: kroohi730@alivecor.com
- Phone: 855-338-8800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.