ST Elevated Myocardial Infarction
Conditions
Brief 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.
Interventions
DEVICEAlivecor Heart Monitor
Sponsors
INTEGRIS Baptist Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 INTEGRIS Baptist 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the number of agreements in diagnoses (STEMI vs. non-STEMI) between the standard 12-lead ECG and the iPhone 12-lead equivalent ECG | 10 Weeks | Number of Agreements |
Countries
United States
Outcome results
None listed