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Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG

Predicting Atrial Fibrillation and Life-threatening Cardiac Arrhythmias and Conduction Disorders in the Perioperative Period in High Cardiac Risk Surgery Using Artificial Intelligence Elements

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07348991
Enrollment
300
Registered
2026-01-16
Start date
2026-12-31
Completion date
2028-05-30
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction, Ventricular Fibrillation, Ventricular Tachycardia (VT)

Keywords

Electrocardiogram, Artificial intelligence, Cardiac arrhythmias, Atrioventricular block, Perioperative, Atrial fibrillation

Brief summary

During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices. This ECG is analyzed for time, amplitude, and frequency parameters-more than 200 parameters per cardiac cycle. Additionally, the available parameters of a standard 12-lead ECG recording are determined. All parameters of both single-lead and 12-lead ECGs will be included in a multivariate regression analysis to determine the optimal method for predicting atrial fibrillation, life-threatening cardiac arrhythmias, and conduction abnormalities in the perioperative period after high-risk cardiac procedures. The study will include patients undergoing high-risk cardiac surgeries, such as those on the heart, aorta, esophagus, pancreas, liver, and lungs, as well as high-risk oncological surgeries. A partial analysis will also be performed depending on the type of intervention. Rhythm and conduction disturbances will be recorded during surgery, as well as in the postoperative period, using ECG monitors, 24-hour ECG monitoring, and repeated recordings of a standard ECG when complaints or signs of unstable hemodynamics arise

Detailed description

In study, the investigators plan to identify single-channel and 12-lead ECG parameters that correlate significantly with the occurrence of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disturbances in the perioperative period after high-risk cardiac interventions. A prospective, non-randomized, observational, controlled, single-center study consisting of two consecutive stages is being conducted. The first stage involves identifying single-channel and 12-lead ECG parameters that correlate significantly with the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk. Participants who meet the inclusion criteria will undergo the following during preoperative preparation: recording of a digital single-channel ECG using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024); a digital 12-lead ECG; an extended echocardiographic examination; and 24-hour Holter ECG monitoring. The single-channel ECG will be recorded for 3 minutes at rest in a sitting position. The participants leans back against the back of the chair, legs uncrossed, arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex. Next, the parameters of single-channel and 12-channel ECG are identified that have a reliable correlation with the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk, followed by the creation of a machine learning model and/or or neural network analysis with deep learning support for predicting the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders. The second stage will involve testing using a test sample of the algorithm, taking into account the ECG parameters which, according to the statistical analysis performed in the first stage, had the highest sensitivity and specificity in predicting the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conductions disorders.

Interventions

DIAGNOSTIC_TESTdigital single-channel ECG recording

A single-channel ECG will be recorded for 3 minutes while the patient is sitting at rest. The patient leans back against the chair, legs uncrossed, and arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex (CardioQVARK medical device (Electrocardiograph) issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare) P3H 2024/22855, issued on June 5, 2024).

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 18 years of age; * Scheduled surgery with high cardiac risk * Informed consent was given to participate in the study

Exclusion criteria

* Cancellation of the surgery for any reason; * The patient's unwillingness to continue participating in the study; * Poor quality of the ECG recording on a single-channel ECG monitor.

Design outcomes

Primary

MeasureTime frameDescription
specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy30 days after sugery startsstatistical parameter of diagnostic and prognostic accuracy of the method under study
specificity, sensitivity, prognostic significance of a positive and negative result, prognostic significance of a positive and positive result, diagnostic accuracyperioperative period - from the surgery starts till 30 days after surgerystatistical parameter of diagnostic and prognostic accuracy of the method under study

Contacts

CONTACTPeter Chomakhidze, Prof.
chomakhidze_p_sh@staff.sechenov.ru+79166740369
CONTACTIvan Kuznetsov, Dr.
ivankuz1310@gmail.com+79688487558

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026