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Clinical trialNCT02498405CompletedObservational

Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction

SponsorIntermountain Health Care, Inc.Enrollment53ST Segment Elevation Myocardial Infarction
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Intermountain Medical Center

    Murray, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2015
Primary completion
31 Oct 2016
Completion
—
Last update posted
1 Aug 2018
Registered enrollment
53
Registry id
NCT02498405

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.