Smartphone Twelve Lead Electrocardiogram Utility In ST Elevation Myocardial Infarction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ST Elevated Myocardial Infarction
- Sponsor
- INTEGRIS Baptist Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Determine the number of agreements in diagnoses (STEMI vs. non-STEMI) between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Charles Bethea
Principal Investigator
INTEGRIS Baptist Medical Center
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 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.
Outcomes
Primary Outcomes
Determine the number of agreements in diagnoses (STEMI vs. non-STEMI) between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG
Time Frame: 10 Weeks
Number of Agreements