NCT04057404

Smartphone Twelve Lead Electrocardiogram Utility In ST Elevation Myocardial Infarction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: INTEGRIS Baptist Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine if the Smartphone electrocardiogram (ECG) is an acceptable replacement for a standard ECG in the identification of ST elevation myocardial infarction (STEMI).

Detailed description

Toward this objective, this study involves the following: * Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting with chest pain in which the STEMI protocol was activated. * Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting to the Emergency Department for evaluation of chest pain, not necessarily presenting with STEMI. * Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are blinded to the initial clinical ECG readings, the type of ECG equipment used, and the patient's clinical information. * Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and * Determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future IRB-approved protocol and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard. There will be no therapeutic interventions. A single research-related procedure will be required, i.e. an iPhone 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. Effort will be made to enroll 1 STEMI patient for every 2 non-STEMI patients.

Conditions

• ST Elevated Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Alivecor Heart Monitor

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2019-08-15
• Last updated: 2019-08-19

Locations

1 site across 1 country: United States