Using a smartphone device to record 12-lead ECGs for heart attack diagnosis
Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (STLEUISII)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AliveCor Industry-sponsored |
| Locations | 4 sites (Rochester, Minnesota and 3 other locations) |
| Trial ID | NCT06271577 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who present with symptoms of chest pain at participating emergency departments.
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.
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 performed: Previous studies, such as the ST LEUIS study, have shown success in validating similar ECG devices for diagnosing myocardial infarctions.
Eligibility criteria
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 this trial is running
Rochester, Minnesota and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.