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

Sponsor

A-Rhythmik GmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT04637230

Collaborator

(none)

10,000

Enrollment

Location

20.9

Anticipated Duration (Months)

477.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sinus Rhythm Atrial Fibrillation Atrial Premature Complexes Ventricular Premature Complexes Ventricular Tachycardia, Nonsustained	Diagnostic Test: Electrocardiogram analysis by Artificial Intelligence

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sinus Rhythm Subjects/patients in normal sinus rhythm	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
Atrial Fibrillation Patients with atrial fibrillation	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
Atrial Premature Complexes Patients with atrial premature complexes in between sinus beats	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
Ventricular Premature Complexes Patients with ventricular premature complexes in between sinus beats	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
Ventricular Tachycardia, Nonsustained Patients with episodes of nonsustained ventricular tachycardia in between sinus beats	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

Outcome Measures

Primary Outcome Measures

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 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)
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

Secondary Outcome Measures

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