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NCT07348991

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

Sponsor: I.M. Sechenov First Moscow State Medical University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-12-31

Completion Date

2028-05-30

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

digital 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).