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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age;

Scheduled surgery with high cardiac risk

Informed consent was given to participate in the study

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: intervention group1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
30 days after sugery starts
2

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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