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

I

INTEGRIS Baptist Medical Center

Status

Completed

Conditions

ST Elevated Myocardial Infarction

Treatments

Device: Alivecor Heart Monitor

Study type

Observational

Funder types

Other

Identifiers

NCT04057404
INT15-017

Details and patient eligibility

About

The primary objective 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).

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female >= 18 years of age.
  • 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 at the INTEGRIS Baptist Medical Center Emergency Department

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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