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

• Conditions: Sinus Rhythm; Atrial Fibrillation; Atrial Premature Complexes; Ventricular Premature Complexes; Ventricular Tachycardia, Nonsustained
• Interventions: Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence

• Registration Number: NCT04637230
• Lead Sponsor: A-Rhythmik GmbH

Brief 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. 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 Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Study Start: 2021-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Primary Completion: 2022-07
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Heart rhythm of interest present on ECG

Exclusion Criteria

• Patient incapable of or not willing to sign informed consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation	Electrocardiogram analysis by Artificial Intelligence	Patients with atrial fibrillation
Ventricular Tachycardia, Nonsustained	Electrocardiogram analysis by Artificial Intelligence	Patients with episodes of nonsustained ventricular tachycardia in between sinus beats
Sinus Rhythm	Electrocardiogram analysis by Artificial Intelligence	Subjects/patients in normal sinus rhythm
Atrial Premature Complexes	Electrocardiogram analysis by Artificial Intelligence	Patients with atrial premature complexes in between sinus beats
Ventricular Premature Complexes	Electrocardiogram analysis by Artificial Intelligence	Patients with ventricular premature complexes in between sinus beats

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of AI	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 QRS-complex fragmentation	Immediate	Assessment of presence ("Yes") or absence ("No") of QRS-complex fragmentation
ECG QTc interval	Immediate	Calculation of heart rate corrected QT interval (QTc) via Bazett formula from measured QT interval
ECG T wave inversion	Immediate	Assessment of presence ("Yes") or absence ("No") of T wave inversion
ECG R-R interval	Immediate	30-sec mean and standard deviation of R-R intervals
ECG QRS-complex duration	Immediate	Measurement of width/duration of QRS complex; distinction between "narrow" (\<=110ms) and "wide" (\>110ms)

Secondary Outcome Measures

Name	Time	Method
ECG P wave	Immediate	Assessment of presence ("Yes") or absence ("No") of P wave on ECG; measurement of P-wave duration (in ms)
ECG PQ interval	Immediate	Measurement of PQ interval (onset of P wave to onset of Q wave) on ECG
ECG QT interval	Immediate	Measurement of QT interval (onset of Q wave to end of T wave) on ECG

Trial Locations

Locations (1)

Universitäres Herzzentrum, Lübeck, Germany; 🇩🇪 Lübeck, Germany