Sinus RhythmPRICENCT04637230
Prevention of Stroke and Sudden Cardiac Death by Recording of 1-Channel Electrocardiograms
An observational study of Sinus Rhythm and Atrial Fibrillation, run by A-Rhythmik GmbH at 1 site in Germany.
Trial summary
Single-channel electrocardiograms (lead I of 12-lead surface ECG; 30 seconds) will be collected from subjects/patients at 11 clinical centers in Germany to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Rhythm, Atrial Fibrillation, Atrial Premature Complexes
- What is being tested?
- Electrocardiogram analysis by Artificial Intelligence
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to 30 Jun 2023
- How long will I take part?
- 1 Day
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from tertiary care centers
Who may be able to join
- Heart rhythm of interest present on ECG
Who cannot join
- Patient incapable of or not willing to sign informed consent form
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitäres Herzzentrum, Lübeck, Germany
Lübeck, 23538
Roza Saraei, PhD, +49451 500 44542, roza.saraei@uksh.de
Michael Schlüter, PhD, +49172 408 9325, meos04@gmx.de
About this study
Single-channel electrocardiograms (lead I of 12-lead surface ECG; 30 seconds) will be collected from subjects/patients at 11 clinical centers in Germany to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms. Heart rhythms of interest are normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). Per diagnosis, 20,000 ECGs are required, for a total of 100,000 ECGs to be obtained from approximately 10,000 subjects/patients.
Read the detailed description
In phase 1 of a research project titled 'Prevention of stroke and sudden cardiac death by Recording of 1-Channel Electrocardiograms' (PRICE), a total of 100,000 30-sec single-channel ECGs (lead I of 12-lead surface ECG) will be collected from approximately 10,000 subjects/patients at 11 participating clinical centers in Germany. Relevant baseline clinical patient characteristics will also be recorded. The ECGs, diagnosed by an experienced electrophysiologist (diagnostic gold standard), will be fed into an Artificial Intelligence (AI) for the automatic detection of normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). It is expected that the overall diagnostic accuracy of the AI against an experienced electrophysiologist will be on the order of 95%.
In PRICE phase 2, ECG diagnosis by the AI will be compared with the diagnosis by 3 general cardiologists of the same ECGs. It is expected that the AI will surpass the general cardiologists in terms of diagnostic accuracy.
The final clinical phase of the PRICE project will comprise a randomized controlled community trial of risk patients to establish the superiority in stroke prevention of AI detection of AF on smart-watch ECGs vs. no AF detection.
- Conditions
- Sinus Rhythm, Atrial Fibrillation, Atrial Premature Complexes, Ventricular Premature Complexes, Ventricular Tachycardia, Nonsustained
- Being tested
- Electrocardiogram analysis by Artificial Intelligence
- Keywords
- Automated ECG diagnosis
- Medical subject headings
- Atrial Fibrillation, Atrial Premature Complexes, Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram analysis by Artificial IntelligenceDiagnostic test
1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms
| Study group | Role | What they receive |
|---|---|---|
| Sinus Rhythm | Subjects/patients in normal sinus rhythm Receives: Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence | |
| Atrial Fibrillation | Patients with atrial fibrillation Receives: Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence | |
| Atrial Premature Complexes | Patients with atrial premature complexes in between sinus beats Receives: Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence | |
| Ventricular Premature Complexes | Patients with ventricular premature complexes in between sinus beats Receives: Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence | |
| Ventricular Tachycardia, Nonsustained | Patients with episodes of nonsustained ventricular tachycardia in between sinus beats Receives: Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of AI
Overall diagnostic accuracy of the AI in the diagnosis of normal SR, AF, APBs, VPBs, and nonsustained VT (gold standard: diagnosis by experienced electrophysiologist)
Measured: 1 year
ECG R-R interval
30-sec mean and standard deviation of R-R intervals
Measured: Immediate
ECG QRS-complex duration
Measurement of width/duration of QRS complex; distinction between "narrow" (<=110ms) and "wide" (>110ms)
Measured: Immediate
ECG QRS-complex fragmentation
Assessment of presence ("Yes") or absence ("No") of QRS-complex fragmentation
Measured: Immediate
ECG QTc interval
Calculation of heart rate corrected QT interval (QTc) via Bazett formula from measured QT interval
Measured: Immediate
ECG T wave inversion
Assessment of presence ("Yes") or absence ("No") of T wave inversion
Measured: Immediate
Secondary outcomes (3)
ECG P wave
Assessment of presence ("Yes") or absence ("No") of P wave on ECG; measurement of P-wave duration (in ms)
Measured: Immediate
ECG PQ interval
Measurement of PQ interval (onset of P wave to onset of Q wave) on ECG
Measured: Immediate
ECG QT interval
Measurement of QT interval (onset of Q wave to end of T wave) on ECG
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Oct 2021
- Primary completionJul 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus RhythmStudies 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
- 10,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- A-Rhythmik GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, MD, Principal investigator, Universitäres Herzzentrum, Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637230
- Sponsor's protocol ID
- 20-139
- Acronym
- PRICE
- Status last verified
- Apr 2022
- First submitted
- 17 Nov 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Stroke and Sudden Cardiac Death by Recording of 1-Channel Electrocardiograms
- ClinicalTrials.gov ID
- NCT04637230
- Acronym / sponsor ID
- PRICE / 20-139
- Conditions
- Sinus Rhythm, Atrial Fibrillation, Atrial Premature Complexes, Ventricular Premature Complexes, Ventricular Tachycardia, Nonsustained
- Keywords
- Automated ECG diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- A-Rhythmik GmbHUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 19 Nov 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-channel electrocardiograms (lead I of 12-lead surface ECG; 30 seconds) will be collected from subjects/patients at 11 clinical centers in Germany to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms. Heart rhythms of interest are normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). Per diagnosis, 20,000 ECGs are required, for a total of 100,000 ECGs to be obtained from approximately 10,000 subjects/patients.
Detailed description
In phase 1 of a research project titled 'Prevention of stroke and sudden cardiac death by Recording of 1-Channel Electrocardiograms' (PRICE), a total of 100,000 30-sec single-channel ECGs (lead I of 12-lead surface ECG) will be collected from approximately 10,000 subjects/patients at 11 participating clinical centers in Germany. Relevant baseline clinical patient characteristics will also be recorded. The ECGs, diagnosed by an experienced electrophysiologist (diagnostic gold standard), will be fed into an Artificial Intelligence (AI) for the automatic detection of normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). It is expected that the overall diagnostic accuracy of the AI against an experienced electrophysiologist will be on the order of 95%.
In PRICE phase 2, ECG diagnosis by the AI will be compared with the diagnosis by 3 general cardiologists of the same ECGs. It is expected that the AI will surpass the general cardiologists in terms of diagnostic accuracy.
The final clinical phase of the PRICE project will comprise a randomized controlled community trial of risk patients to establish the superiority in stroke prevention of AI detection of AF on smart-watch ECGs vs. no AF detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sinus Rhythm | – | Diagnostic Test: Electrocardiogram analysis by Artificial IntelligenceSubjects/patients in normal sinus rhythm |
| Atrial Fibrillation | – | Diagnostic Test: Electrocardiogram analysis by Artificial IntelligencePatients with atrial fibrillation |
| Atrial Premature Complexes | – | Diagnostic Test: Electrocardiogram analysis by Artificial IntelligencePatients with atrial premature complexes in between sinus beats |
| Ventricular Premature Complexes | – | Diagnostic Test: Electrocardiogram analysis by Artificial IntelligencePatients with ventricular premature complexes in between sinus beats |
| Ventricular Tachycardia, Nonsustained | – | Diagnostic Test: Electrocardiogram analysis by Artificial IntelligencePatients with episodes of nonsustained ventricular tachycardia in between sinus beats |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from tertiary care centers
Key inclusion criteria (1 listed)
- Heart rhythm of interest present on ECG
Key exclusion criteria (1 listed)
- Patient incapable of or not willing to sign informed consent form
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 |
|---|---|---|
| Electrocardiogram analysis by Artificial Intelligence1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms | Diagnostic test | Atrial Fibrillation, Atrial Premature Complexes, Sinus Rhythm, Ventricular Premature Complexes, Ventricular Tachycardia, Nonsustained |
Primary outcome
Diagnostic accuracy of AI
Time frame: 1 year
Overall diagnostic accuracy of the AI in the diagnosis of normal SR, AF, APBs, VPBs, and nonsustained VT (gold standard: diagnosis by experienced electrophysiologist)
ECG R-R interval
Time frame: Immediate
30-sec mean and standard deviation of R-R intervals
ECG QRS-complex duration
Time frame: Immediate
Measurement of width/duration of QRS complex; distinction between "narrow" (<=110ms) and "wide" (>110ms)
ECG QRS-complex fragmentation
Time frame: Immediate
Assessment of presence ("Yes") or absence ("No") of QRS-complex fragmentation
ECG QTc interval
Time frame: Immediate
Calculation of heart rate corrected QT interval (QTc) via Bazett formula from measured QT interval
ECG T wave inversion
Time frame: Immediate
Assessment of presence ("Yes") or absence ("No") of T wave inversion
3 secondary outcomes
ECG P wave
Time frame: Immediate
ECG PQ interval
Time frame: Immediate
ECG QT interval
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Karl-Heinz Kuck, MD principal investigator
Universitäres Herzzentrum, Lübeck, Germany
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 Sinus Rhythm and Atrial Fibrillation, run by A-Rhythmik GmbH at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Heinz Kuck, MD (+49451 500 75301, karl-heinz.kuck@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of AI (time frame: 1 year). The study lists 6 primary outcomes in all. 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 6 Apr 2022.