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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction; Cardiovascular Diseases; Vascular Diseases; Ischemia; Heart Diseases; Myocardial Ischemia; Heart Attack; Heart Failure
• Interventions: Device: AliveCor 12-lead ECG

• Registration Number: NCT06271577
• Lead Sponsor: AliveCor

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-22
• Study Start: 2024-03-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AliveCor 12-lead ECG	AliveCor 12-lead ECG	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.

Primary Outcome Measures

Name	Time	Method
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI	30 seconds
Inter-rater variability for AC 12L ECG readings	30 seconds
Inter-rater variability for Standard 12-lead ECG readings	30 seconds
Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI	30 seconds
Number of standard 12-lead ECG readings requiring a consensus consultation	30 seconds
Number of AC 12L ECG readings requiring a consensus consultation	30 seconds
Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI	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	30 seconds
Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI	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	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	30 seconds

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Intermountain Health; 🇺🇸 Murray, Utah, United States