Myocardial InfarctionSTLEUISIINCT06271577
Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II
A study testing AliveCor 12-lead ECG in people with Myocardial Infarction and Ischemia, run by AliveCor at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Ischemia, Myocardial Ischemia
- What is being tested?
- AliveCor 12-lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Mar 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Intermountain Health
Murray, Utah, 84107
Heather Maestas, 801-680-1931 ext. 7495, Heather.Maestas@imail.org
Lorlie Evans, 801-369-2966 ext. 74753, Lorlie.Evans@imail.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Julianne Rumer, 507-255-1034, Rumer.Julianne@mayo.edu
Anna Pick, 507-775-0630, Pick.Anna@mayo.edu
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
University of Edinburgh
Edinburgh, Scotland
Paul Fineran, +0 000 0000 00, pfineran@exseed.ed.ac.uk
Michael McDermott, MD
- Not yet recruiting
Leeds General Infirmary
Leeds, England
Melanie Spurr, +0 000 0000 00, Melanie.Spurr@nhs.net
Lucy Ogley, Lucy.Ogley1@nhs.net
About this study
Official title: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (STLEUISII)
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
- Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
- Being tested
- AliveCor 12-lead ECG
- Medical subject headings
- Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliveCor 12-lead ECGDevice
The primary objective of this study is to determine if the AliveCor 12-lead Smartphone ECG is an acceptable substitute for a standard 12-lead ECG in the identification of STEMI and NSTEMI.
| Study group | Role | What they receive |
|---|---|---|
| AliveCor 12-lead ECG | Experimental | A single research-related procedure will be required (i.e., an AliveCor 12-lead ECG). Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires. Receives: Device: AliveCor 12-lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater variability for Standard 12-lead ECG readings
Measured: 30 seconds
Inter-rater variability for AC 12L ECG readings
Measured: 30 seconds
Number of standard 12-lead ECG readings requiring a consensus consultation
Measured: 30 seconds
Number of AC 12L ECG readings requiring a consensus consultation
Measured: 30 seconds
Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Measured: 30 seconds
Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Measured: 30 seconds
Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Measured: 30 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 STEMI
Measured: 30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI
Measured: 30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI
Measured: 30 seconds
Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start12 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AliveCor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271577
- Sponsor's protocol ID
- PRO-0013
- Acronym
- STLEUISII
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31986289
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II (STLEUISII)
- ClinicalTrials.gov ID
- NCT06271577
- Acronym / sponsor ID
- STLEUISII / PRO-0013
- Conditions
- Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AliveCorIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AliveCor 12-lead ECG | Experimental | Device: AliveCor 12-lead ECGA single research-related procedure will be required (i.e., an AliveCor 12-lead ECG). Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AliveCor 12-lead ECGThe primary objective of this study is to determine if the AliveCor 12-lead Smartphone ECG is an acceptable substitute for a standard 12-lead ECG in the identification of STEMI and NSTEMI. | Device | AliveCor 12-lead ECG |
Primary outcome
Inter-rater variability for Standard 12-lead ECG readings
Time frame: 30 seconds
Inter-rater variability for AC 12L ECG readings
Time frame: 30 seconds
Number of standard 12-lead ECG readings requiring a consensus consultation
Time frame: 30 seconds
Number of AC 12L ECG readings requiring a consensus consultation
Time frame: 30 seconds
Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time frame: 30 seconds
Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time frame: 30 seconds
Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI
Time frame: 30 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 STEMI
Time frame: 30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI
Time frame: 30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI
Time frame: 30 seconds
Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs
Time frame: 30 seconds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 31986289Muhlestein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AliveCor 12-lead ECG in people with Myocardial Infarction and Ischemia, run by AliveCor at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Roohi, MS (855-338-8800, kroohi730@alivecor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater variability for Standard 12-lead ECG readings (time frame: 30 seconds). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06271577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.