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

Atrial Fibrillation Clinical Trial

— PRICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637230
• Other study ID #: 20-139
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: Lanserhof
• Contact: Karl-Heinz Kuck, MD
• Phone: +49451 500 75301
• Email: karl-heinz.kuck[@]uksh.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Heart rhythm of interest present on ECG

Exclusion Criteria:

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

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

Intervention

Diagnostic Test:
• Electrocardiogram analysis by Artificial Intelligence
1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms

Locations

Country	Name	City	State
Germany	Universitäres Herzzentrum, Lübeck, Germany	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
A-Rhythmik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	ECG R-R interval	30-sec mean and standard deviation of R-R intervals	Immediate
Primary	ECG QRS-complex duration	Measurement of width/duration of QRS complex; distinction between "narrow" (<=110ms) and "wide" (>110ms)	Immediate
Primary	ECG QRS-complex fragmentation	Assessment of presence ("Yes") or absence ("No") of QRS-complex fragmentation	Immediate
Primary	ECG QTc interval	Calculation of heart rate corrected QT interval (QTc) via Bazett formula from measured QT interval	Immediate
Primary	ECG T wave inversion	Assessment of presence ("Yes") or absence ("No") of T wave inversion	Immediate
Secondary	ECG P wave	Assessment of presence ("Yes") or absence ("No") of P wave on ECG; measurement of P-wave duration (in ms)	Immediate
Secondary	ECG PQ interval	Measurement of PQ interval (onset of P wave to onset of Q wave) on ECG	Immediate
Secondary	ECG QT interval	Measurement of QT interval (onset of Q wave to end of T wave) on ECG	Immediate