protocolSection identificationModule nctId: NCT06271577, orgStudyIdInfo id: PRO-0013, briefTitle: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II, acronym: STLEUISII, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: AliveCor, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Myocardial Infarction, conditions: Ischemia, conditions: Myocardial Ischemia, conditions: Heart Diseases, conditions: Cardiovascular Diseases, conditions: Vascular Diseases, conditions: Heart Attack, conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: AliveCor 12-lead ECG, outcomesModule primaryOutcomes measure: Inter-rater variability for Standard 12-lead ECG readings, primaryOutcomes measure: Inter-rater variability for AC 12L ECG readings, primaryOutcomes measure: Number of standard 12-lead ECG readings requiring a consensus consultation, primaryOutcomes measure: Number of AC 12L ECG readings requiring a consensus consultation, primaryOutcomes measure: Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: 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, primaryOutcomes measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI, primaryOutcomes measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI, primaryOutcomes measure: Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Julianne Rumer, role: CONTACT, phone: 507-255-1034, email: Rumer.Julianne@mayo.edu, contacts name: Anna Pick, role: CONTACT, phone: 507-775-0630, email: Pick.Anna@mayo.edu, contacts name: Gregory Barsness, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False