Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction

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.