Prevention of Stroke and Sudden Cardiac Death by Recording of 1-Channel Electrocardiograms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Stroke and Sudden Cardiac Death by Recording of 1-Channel Electrocardiograms

Conditions
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Sinus Rhythm, Atrial Fibrillation, Atrial Premature Complexes, Ventricular Premature Complexes, Ventricular Tachycardia, Nonsustained

Intervention / Treatment
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* Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart rhythm of interest present on ECG Exclusion Criteria: Patient incapable of or not willing to sign informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sinus Rhythm<br>Subjects/patients in normal sinus rhythm | Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence<br>* 1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms<br>|
| Atrial Fibrillation<br>Patients with atrial fibrillation | Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence<br>* 1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms<br>|
| Atrial Premature Complexes<br>Patients with atrial premature complexes in between sinus beats | Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence<br>* 1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms<br>|
| Ventricular Premature Complexes<br>Patients with ventricular premature complexes in between sinus beats | Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence<br>* 1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms<br>|
| Ventricular Tachycardia, Nonsustained<br>Patients with episodes of nonsustained ventricular tachycardia in between sinus beats | Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence<br>* 1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Immediate | 
| ECG QT interval | Measurement of QT interval (onset of Q wave to end of T wave) on ECG | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated ECG diagnosis