At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AliveCor 12-lead ECG (device)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- AliveCor 12-lead ECG — device: 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how useful a twelve-lead electrocardiogram (ECG – a test that records the heart's electrical activity) done on a smartphone is for people having a serious type of heart attack called an ST-elevation myocardial infarction (STEMI). It involves people who come to the emergency department with chest pain. The study is sponsored (paid for) by a company called AliveCor.
Who can take part
- Adults aged over 18
- Able to understand and sign a written consent form before any study steps begin
- Have chest pain when arriving at the emergency department of the hospital taking part
Who may not be able to
- Unable or unwilling to give written consent (this can also apply to the patient's legal representative)
- Any other condition that, in the Lead Investigator's opinion, could increase risk to the person taking part or affect the quality of the trial
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2024-03-12
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for myocardial infarction
- • NA - 1,000 participants
- • AliveCor (www
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with myocardial infarction
Where?
- • Leeds - Leeds General Infirmary
- • Edinburgh - University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Male or female \> 18 years of age.
- ✓Ability to understand and sign a written agreement to take part form, which must be obtained prior to initiation of any...
- ✓Symptoms of chest pain upon presentation at the Emergency Department of the participating institution.
Who cannot take part
- ✗Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written...
- ✗Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the...
See the full criteria
Where Is This Study? (2 UK sites)
Leeds General Infirmary
Leeds, United Kingdom
University of Edinburgh
Edinburgh, United Kingdom
How to Get in Touch
Kimberly Roohi, MS
Sponsor contactCONTACT