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

This study is looking at whether a new device, the AliveCor 12-lead ECG, which works with smartphones, can accurately detect heart attacks (Myocardial Infarction) as well as a standard 12-lead ECG. Researchers want to see if this smartphone-based device can be a good alternative for identifying two types of heart attacks: ST-Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI). You may be able to join if you are 18 or older, can give informed consent, and come to the Emergency Department with chest pain. The study will be successful if the AliveCor 12-lead ECG readings are similar to standard ECG readings, and if there's agreement among doctors interpreting the results.

Study design
This interventional study plans to enroll 1000 participants. It aims to compare the AliveCor 12-lead ECG device to a standard 12-lead ECG.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 30 seconds.

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NCT06271577

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

Recruiting
NAAges 18+InterventionalDiagnostic
AliveCor
~1,000 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:AliveCor 12-lead ECG

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Inter-rater variability for Standard 12-lead ECG readings
Measured over 30 seconds
+10 more outcomes measured

Conditions

Myocardial Infarction
Ischemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Attack
Heart Failure

Explore related trials

Myocardial Infarction

Where it's being run

4 sites across 4 states
Minnesota1
Utah1
England1
Scotland1

Who to contact

Kimberly Roohi, MS
[email protected]
855-338-8800
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Inter-rater variability for Standard 12-lead ECG readings30 seconds
  • Inter-rater variability for AC 12L ECG readings30 seconds
  • Number of standard 12-lead ECG readings requiring a consensus consultation30 seconds
  • Number of AC 12L ECG readings requiring a consensus consultation30 seconds
  • Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI30 seconds
  • Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI30 seconds
  • Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI30 seconds
  • Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI30 seconds
  • Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI30 seconds
  • Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI30 seconds
  • Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs30 seconds