ST LEUIS: Smartphone Twelve Lead Electrocardiogram Utility In ST Elevation Myocardial Infarction
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Toward this objective, this study involves the following:
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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.
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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.
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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.
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Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female >= 18 years of age.
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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).
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Symptoms of chest pain upon presentation at the INTEGRIS Baptist Medical Center Emergency Department
Exclusion Criteria:
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Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide written informed consent for any reason.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73162 |
Sponsors and Collaborators
- INTEGRIS Baptist Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INT15-017