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NCT02498405 · ClinicalTrials.gov registry record
Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction
A clinical trial, sponsored by Intermountain Health Care.
- Completed
- Registry status
- 53
- Enrollment target
NCT02498405: Completed study, sponsored by Intermountain Health Care.
NCT02498405 is a clinical trial that has completed, run by Intermountain Health Care. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02498405 has completed, sponsored by Intermountain Health Care.
- COMPLETED
- Registry status
- 53 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Determine the number of agreements in diagnoses (STEMI vs. non-STEMI) between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2015-12 |
What the finished NCT02498405 record still lists
NCT02498405 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02498405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02498405 about?
NCT02498405 is a clinical study titled "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 recordi...
What is the current status of trial NCT02498405?
This trial is currently completed. The enrollment target is 53 participants. The study started on 2015-12.
Who is sponsoring clinical trial NCT02498405?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
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