Cardiac ArrhythmiaINTERPRET-AF INCT04374344
Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias
An observational study of Cardiac Arrhythmia, run by Qompium NV at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Mar 2020to 24 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Medical professionals including cardiologists and cardiology residents with and without experience in qualitative analysis of PPG waveforms.
Who may be able to join
- Cardiologist or cardiology resident
- Able to understand Dutch or English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements
- Keywords
- Qualitative analysis, Photoplethysmography, Single-lead electrocardiography
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurementsOther
Participants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces.
| Study group | Role | What they receive |
|---|---|---|
| Medical professionals | Medical professionals including cardiologists and cardiology residents. Receives: Other: Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy to discriminate between atrial fibrillation and non-atrial fibrillation rhythms
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.
Measured: Through study completion, an average of 3 months
Secondary outcomes (2)
Required elements to increase the readability of PPG measurements
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.
Measured: Through study completion, an average of 3 months
Diagnostic accuracy of PPG analysis: experienced in PPG analysis vs inexperienced in PPG analysis
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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start10 Mar 2020
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qompium NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pieter Vandervoort, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374344
- Sponsor's protocol ID
- 3
- Acronym
- INTERPRET-AF I
- Status last verified
- Dec 2020
- First submitted
- 28 Apr 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias Using a Pulse-deriving Smartphone Application
- ClinicalTrials.gov ID
- NCT04374344
- Acronym / sponsor ID
- INTERPRET-AF I / 3
- Conditions
- Cardiac Arrhythmia
- Keywords
- Qualitative analysis, Photoplethysmography, Single-lead electrocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Qompium NVIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical professionals | – | Other: Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurementsMedical professionals including cardiologists and cardiology residents. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Medical professionals including cardiologists and cardiology residents with and without experience in qualitative analysis of PPG waveforms.
Key inclusion criteria (2 listed)
- Cardiologist or cardiology resident
- Able to understand Dutch or English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurementsParticipants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces. | Other | Medical professionals |
Primary outcome
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.
2 secondary outcomes
Required elements to increase the readability of PPG measurements
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Vandervoort, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Qompium NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy to discriminate between atrial fibrillation and non-atrial fibrillation rhythms (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.