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Completed

NCT Number: NCT04374344

Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias

Single-lead electrocardiography (ECG) technologies and photoplethysmography (PPG) deriving smartphone apps are gaining interest in the heart rhythm detection space since these apps have the potential to capture and assess heart rhythms. Proprietary arrhythmia detection algorithms are proven to be reliable and accurate. However, insights into the readability of PPG waveforms by human reviewers remain limited. To the investigators' knowledge, there are no publications available regarding the readability of PPG waveforms by human reviewers. The objective of the study was to assess the readability of PPG and single-lead ECG analysis by medical professionals, with respect to the gold-standard 12-lead ECG diagnosis, and investigate whether additional information positively impacts PPG analysis.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

About this study

During the study, the readability of PPG and single-lead ECG waveform analysis will be investigated. The objective of the study is to determine the readability of PPG and single-lead ECG measurements, with respect to the gold-standard 12-lead ECG, and investigate whether additional information positively impacts the readability of PPG. Medical professionals (cardiologists and cardiology residents), blinded for the patients' characteristics and history, are instructed to separately analyse the following signals, obtained from 30 patients.

  • 30 outputs with PPG waveforms
  • 30 outputs with PPG waveforms with tachogram and Poincaré
  • 30 outputs with PPG waveforms with tachogram, Poincaré, and algorithm interpretation
  • 30 outputs with single-lead ECG waveforms
  • 30 outputs with 12-lead ECG waveforms

Participants report the results of the qualitative analysis via a digital questionnaire with multiple-choice questions. Medical professionals classify each rhythm trace as regular rhythm, one or more ectopic/missed heartbeats, atrial flutter, atrial fibrillation, unreadable, or other. The tachogram, Poincaré, and the algorithm interpretation are subsequently added to investigate whether the additional information improves the readability of PPG. Based on the provided answers, the study team will determine the readability of PPG and single-lead ECG analysis interpretation, with respect to the gold-standard 12-lead ECG diagnosis.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiologist or cardiology resident
  • Able to understand Dutch or English

Treatment and study plan

Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements

Other

Participants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces.

Primary outcomes

  1. Diagnostic accuracy to discriminate between atrial fibrillation and non-atrial fibrillation rhythms

    Time frame: Through study completion, an average of 3 months

    Readability assessment (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of PPG and single-lead ECG signals to detect atrial fibrillation. The readability will be determined and compared with the gold-standard 12-lead ECG diagnosis.

Secondary outcomes

  1. Required elements to increase the readability of PPG measurements

    Time frame: Through study completion, an average of 3 months

    Readability assessment (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of PPG waveforms, PPG waveforms with tachogram and Poincaré, and PPG waveforms with tachogram, Poincaré and algorithm interpretation. The readability will be determined and compared with the gold-standard 12-lead ECG diagnosis.

  2. Diagnostic accuracy of PPG analysis: experienced in PPG analysis vs inexperienced in PPG analysis

    Time frame: Through study completion, an average of 3 months

    Readability assessment (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of PPG waveforms, PPG waveforms with tachogram and Poincaré, and PPG waveforms with tachogram, Poincaré and algorithm interpretation. The readability will be determined and compared with the gold-standard 12-lead ECG diagnosis.

Sponsors and collaborators

Lead sponsor

Qompium NV

Industry

Registry information

Official study title

Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias Using a Pulse-deriving Smartphone Application

Acronym: INTERPRET-AF I

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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