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

NCT07348991 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-02-10

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-06-30
Completion
2028-05-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348991 on ClinicalTrials.gov