Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias (INTERPRET-AF I)

December 1, 2020 updated by: Qompium NV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical professionals including cardiologists and cardiology residents with and without experience in qualitative analysis of PPG waveforms.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medical professionals
Medical professionals including cardiologists and cardiology residents.
Other: Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements
Participants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 months
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.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qompium NV

Investigators

  • Principal Investigator: Pieter Vandervoort, MD, Ziekenhuis Oost-Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

November 24, 2020

Study Completion (Actual)

November 24, 2020

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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