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

RecruitingNAAges 18 Years - anyAllAliveCor
NCT06271577 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • AliveCor 12-lead ECG
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Where

4 sites
Mayo Clinic
Rochester, United States
Intermountain Health
Murray, United States
Leeds General Infirmary
Leeds, United Kingdom
University of Edinburgh
Edinburgh, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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