Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction

NCT03037229 | Completed FDA Device

• 1 other identifier: 16-004793
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

STEMI

Keywords

Myocardial Infarction; Ischemia; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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; 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; Device: Standard 12-lead ECG

Interventions

Smartphone ECG DEVICE

Also known as: AliveCor Kardia Heart Monitor

Chest Pain; STEMI

Standard 12-lead ECG DEVICE

Chest Pain; STEMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• AliveCor: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction; Ischemia; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Gregory W Barsness, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: December 29, 2016
• Primary Completion: January 30, 2018
• Study Completion: December 6, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)