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

Sponsor
I.M. Sechenov First Moscow State Medical University
Study ID
NCT07348991
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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

Key Dates

First listed
Jan 16, 2026
Start date
Dec 31, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
May 30, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: intervention group
    patients meeting the inclusion criteria who are hospitalised for surgery with a high cardiovascular risk

Primary Outcome Measure

specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy [ Time Frame: 30 days after sugery starts ]

Central Contacts

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