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

NCT07348991 | Not Yet Recruiting DMC

• 1 other identifier: ChPSH1
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy

  statistical parameter of diagnostic and prognostic accuracy of the method under study

  30 days after sugery starts

• specificity, sensitivity, prognostic significance of a positive and negative result, prognostic significance of a positive and positive result, diagnostic accuracy

  statistical parameter of diagnostic and prognostic accuracy of the method under study

  perioperative period - from the surgery starts till 30 days after surgery

Study Arms (1)

intervention group

patients meeting the inclusion criteria who are hospitalised for surgery with a high cardiovascular risk

Diagnostic Test: digital single-channel ECG recording

Interventions

digital single-channel ECG recording DIAGNOSTIC_TEST

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).

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will analyze patients undergoing elective high-risk cardiac surgeries, including cardiac surgery, aortic surgery, esophageal and gastric cardia surgery, and thoracic surgery. Patients undergoing large-scale oncological surgeries will also be included.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Related Publications (2)

• Paroxysms of atrial fibrillation during planned cardiac surgery under artificial circulation / E. P. Gulyaeva-Seltsovskaya, I. Dkhif, A. A. Mols [et al.] // Bulletin of the Smolensk State Medical Academy. - 2023. - Vol. 22, No. 4. - P. 100-106. - DOI 10.37903/vsgma.2023.4.14. - EDN MIIWSU

  BACKGROUND

• Chomakhidze P.Sh., Kurbanalieva N.K., Nebezhev A.A., Sedov V.P., Syrkin A.L. Modern aspects of preoperative examination in planned extracardiac interventions. Consilium Medicum. 2025;27(1): DOI: 10.26442/20751753.2025.1.203060 © CONSILIUM MEDICUM LLC, 2025

  BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Atrioventricular Block; Neoplasm Metastasis; Sick Sinus Syndrome; Tachycardia, Ventricular; Ventricular Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease; Neoplastic Processes; Neoplasms; Arrhythmia, Sinus; Tachycardia

Central Study Contacts

Peter Chomakhidze, Prof.

CONTACT

+79166740369; chomakhidze_p_sh@staff.sechenov.ru

Ivan Kuznetsov, Dr.

CONTACT

+79688487558; ivankuz1310@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 10, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 01.2026-01.2028
• Access Criteria: email call