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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Sep 11, 2023
Open Peer Review Period: Sep 11, 2023 - Nov 6, 2023
Date Accepted: Apr 2, 2024
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Mobile Electrocardiograms in the Detection of Subclinical Atrial Fibrillation in High-Risk Outpatient Populations: Protocol for an Observational Study

Mittal A, Elkaldi Y

Mobile Electrocardiograms in the Detection of Subclinical Atrial Fibrillation in High-Risk Outpatient Populations: Protocol for an Observational Study

JMIR Res Protoc 2024;13:e52647

DOI: 10.2196/52647

PMID: 38801762

PMCID: 11165282

Mobile ECGs in Detection of Subclinical Atrial Fibrillation in High Risk Outpatient Populations: Protocol for an Observational Study

  • Ajay Mittal; 
  • Yasmine Elkaldi

ABSTRACT

Background:

Single-lead, smartphone-based mobileECGs have the potential to provide a non-invasive, rapid and cost effective means of screening for atrial fibrillation (AFib) in outpatient non-cardiology specialty clinics. AFib has been associated with various comorbid diseases that prompt further investigation and screening methodologies for at-risk populations. Individuals in vulnerable outpatient populations are at greater risk for developing arrhythmias and a simple 30-second sinus rhythm strip from the KardiaMobile ECG can provide an effective screen for cardiac rhythm abnormalities.

Objective:

The purpose of this study is to determine whether smartphone KardiaMobile Single Lead ECGs are an effective means to accurately detect previously undetected atrial fibrillation (AF) for patients at six different UF outpatient clinics; UF Nephrology Clinic, UF Sleep Clinic, UF Neurology Clinic, UF Ophthalmology clinic, UF Urology Clinic and UF pre-surgical center . . The goal is to identify if this new instrument and its routine rhythm sampling can be utilized in outpatient clinics for patients who are predisposed to cardiovascular disease. Analysis will be done to measure whether this technology can be utilized cost-effectively in an outpatient clinic to provide quick quality screening, and its diagnostic capabilities - potentially serving as an additional vital sign collected during patient encounters. This study will seek to evaluate the efficacy of utilizing smartphone-based KardiaMobile Single Lead ECG technology within pre-identified UF Health Outpatient clinics with populations at high risk for developing atrial fibrillation.

Methods:

Participants were recruited across 6 clinic sites; UF Health Nephrology, UF Health Sleep Center, UF Health Ophthalmology, UF Health Urology, UF Health Neurology and UF Health Pre-Surgical clinic. Participants, between ages 18-99, that agreed to partake in the study were given a consent form and completed a questionnaire covering past medical history and risk factors for cardiovascular disease. Single-lead, 30 second ECGs were taken by the KardiaMobile ECG device. If patients are found to have newly diagnosed AFib, the attending physician is notified, and a 12-lead ECG or standard ECG equivalent will be ordered.

Results:

As of September 1st, 2023, 2153 of 3930 participants have been enrolled. This represents 54% of the studies total. Site specific enrollment numbers differ depending on data collection start date and general clinic volume flow. Of the data collected thus far, the KardiaMobile rhythm strip reported 298 abnormal readings which are pending analysis from a cardiologist. 75 readings were labeled as possible atrial fibrillation, 176 readings were labeled unclassified and 47 were unreadable. Of note, the average age of participants was 61.9, and the average self-reported weight was 198.64 pounds. Additionally, 24.6% of participants reported a history of being diagnosed with hypertension; 7.5% reported having heart stents; 18.9% reported having a history of congestive heart failure, heart attack, and coronary artery disease; and 8.5% reported a previous diagnosis of AFib. Additionally, 66.8% of participants report not regularly seeing a cardiologist. Potential applications in free clinics could improve screening capabilities while minimizing costs.

Conclusions:

Preliminary data shows promise regarding the feasibility of using KardiaMobile ECGs for the screening of AFib and prevention of cardiological disease in vulnerable outpatient populations. The utilization of a single-lead mobileECG strip can serve as a low cost, effective atrial fibrillation screen for implementation across free clinics attempting to provide accessible healthcare for all.


 Citation

Please cite as:

Mittal A, Elkaldi Y

Mobile Electrocardiograms in the Detection of Subclinical Atrial Fibrillation in High-Risk Outpatient Populations: Protocol for an Observational Study

JMIR Res Protoc 2024;13:e52647

DOI: 10.2196/52647

PMID: 38801762

PMCID: 11165282

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