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

Atrial Fibrillation Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Premature Complexes
• Death
• Death, Sudden, Cardiac
• Premature Birth
• Sinus Rhythm
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia, Nonsustained

• NCT number: NCT04637230
• Study type: Observational [Patient Registry]
• Source: Lanserhof
• Contact: Karl-Heinz Kuck, MD
• Phone: +49451 500 75301
• Email: karl-heinz.kuck@uksh.de
• Status: Recruiting
• Start date: October 1, 2021
• Completion date: June 30, 2023