Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction (ST LEUIS Study)

Intermountain Health Care, Inc.1 site in 1 country53 target enrollmentDecember 2015

ConditionsST Segment Elevation Myocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ST Segment Elevation Myocardial Infarction
Sponsor: Intermountain Health Care, Inc.
Enrollment: 53
Locations: 1
Primary Endpoint: Diagnosis differences
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study 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).

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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

October 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Intermountain Health Care, Inc.

Responsible Party

Sponsor

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 (patient or legally acceptable representative).
•Symptoms of chest pain upon presentation at the Intermountain Medical Center Emergency Department.

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 Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.