STEMI
Conditions
Keywords
Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
Brief summary
Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).
Detailed description
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 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. The individual patient's participation in the study will actually be only one day, i.e., the day the informed consent is obtained and the two comparison ECGs will be done.
Interventions
DEVICESmartphone ECG
DEVICEStandard 12-lead ECG
Sponsors
AliveCor
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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 |
|---|---|
| Number of patients for whom the diagnoses (STEMI vs. non-STEMI) was in agreement between the standard 12-lead ECG and the iPhone 12-lead equivalent ECG. | Day 1 |
Countries
United States
Outcome results
None listed