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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinus Rhythm | Subjects/patients in normal sinus rhythm |
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| Atrial Fibrillation | Patients with atrial fibrillation |
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| Atrial Premature Complexes | Patients with atrial premature complexes in between sinus beats |
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| Ventricular Premature Complexes | Patients with ventricular premature complexes in between sinus beats |
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| Ventricular Tachycardia, Nonsustained | Patients with episodes of nonsustained ventricular tachycardia in between sinus beats |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram analysis by Artificial Intelligence | Diagnostic Test | 1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| ECG R-R interval | 30-sec mean and standard deviation of R-R intervals | Immediate |
| ECG QRS-complex duration | Measurement of width/duration of QRS complex; distinction between "narrow" (<=110ms) and "wide" (>110ms) | Immediate |
| ECG QRS-complex fragmentation | Assessment of presence ("Yes") or absence ("No") of QRS-complex fragmentation | Immediate |
| ECG QTc interval | Calculation of heart rate corrected QT interval (QTc) via Bazett formula from measured QT interval | Immediate |
| ECG T wave inversion | Assessment of presence ("Yes") or absence ("No") of T wave inversion | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| ECG P wave | Assessment of presence ("Yes") or absence ("No") of P wave on ECG; measurement of P-wave duration (in ms) | Immediate |
| ECG PQ interval | Measurement of PQ interval (onset of P wave to onset of Q wave) on ECG |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from tertiary care centers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl-Heinz Kuck, MD | Contact | +49451 500 75301 | karl-heinz.kuck@uksh.de | |
| Michael Schlüter, PhD | Contact | +49172 4089325 | meos04@gmx.de |
| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, MD | Universitäres Herzzentrum, Lübeck, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäres Herzzentrum, Lübeck, Germany | Recruiting | Lübeck | 23538 | Germany |
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| Immediate |
| ECG QT interval | Measurement of QT interval (onset of Q wave to end of T wave) on ECG | Immediate |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D018880 | Atrial Premature Complexes |
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |
| D000075224 | Cardiac Conduction System Disease |
| D013610 | Tachycardia |
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