Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction (ST LEUIS)

Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).

Study Overview

• Status: Completed
• Conditions: STEMI
• Intervention / Treatment: Device: Smartphone ECG; Device: Standard 12-lead ECG

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or female patients, >18 years old, who are seen for chest pain, and/or patients for whom the STEMI protocol has been activated, will be screened for this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI; Subjects in which a STEMI protocol has been initiated.; An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG; If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG; If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU; Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists	Device: Smartphone ECG; Other Names: AliveCor Kardia Heart Monitor; Device: Standard 12-lead ECG
Chest Pain; Subjects presenting at the emergency department with chest pain.; An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG; If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG; If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU; Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists	Device: Smartphone ECG; Other Names: AliveCor Kardia Heart Monitor; Device: Standard 12-lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: AliveCor
• Investigators: Principal Investigator: Gregory W Barsness, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2016
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Ischemia; Myocardial Infarction; Heart Diseases; Myocardial Ischemia
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 16-004793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes