NCT06271577 Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II
| NCT ID | NCT06271577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AliveCor |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-03-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06271577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06271577 currently recruiting?
Yes, NCT06271577 is actively recruiting participants. Contact the research team at kroohi730@alivecor.com for enrollment information.
Where is the NCT06271577 trial being conducted?
This trial is being conducted at Rochester, United States, Murray, United States, Leeds, United Kingdom, Edinburgh, United Kingdom.
Who is sponsoring the NCT06271577 clinical trial?
NCT06271577 is sponsored by AliveCor. The trial plans to enroll 1,000 participants.