Predicting Atrial Fibrillation and Life-threatening Cardiac Arrhythmias and Conduction Disorders in the Perioperative Period in High Cardiac Risk Surgery Using Artificial Intelligence Elements
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy
研究概览
简要总结
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
详细描述
In study, the investigators plan to identify single-channel and 12-lead ECG parameters that correlate significantly with the occurrence of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disturbances in the perioperative period after high-risk cardiac interventions.
A prospective, non-randomized, observational, controlled, single-center study consisting of two consecutive stages is being conducted.
The first stage involves identifying single-channel and 12-lead ECG parameters that correlate significantly with the onset of atrial fibrillation and life-threatening cardiac arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk. Participants who meet the inclusion criteria will undergo the following during preoperative preparation: recording of a digital single-channel ECG 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); a digital 12-lead ECG; an extended echocardiographic examination; and 24-hour Holter ECG monitoring.
The single-channel ECG will be recorded for 3 minutes at rest in a sitting position. The participants leans back against the back of the chair, legs uncrossed, arms resting on the knees or on the table. Standard lead I is recorded using the CardioQVARK software and hardware complex.
Next, the parameters of single-channel and 12-channel ECG are identified that have a reliable correlation with the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders in the perioperative period after interventions with high cardiac risk, followed by the creation of a machine learning model and/or or neural network analysis with deep learning support for predicting the occurrence of atrial fibrillation and life-threatening arrhythmias and conduction disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age;
- •Scheduled surgery with high cardiac risk
- •Informed consent was given to participate in the study
排除标准
- •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.
研究组 & 干预措施
intervention group
patients meeting the inclusion criteria who are hospitalised for surgery with a high cardiovascular risk
干预措施: digital single-channel ECG recording (Diagnostic Test)
结局指标
主要结局
specificity, sensitivity, prognostic significance of a positive and negative result, diagnostic accuracy
时间窗: 30 days after sugery starts
statistical parameter of diagnostic and prognostic accuracy of the method under study
specificity, sensitivity, prognostic significance of a positive and negative result, prognostic significance of a positive and positive result, diagnostic accuracy
时间窗: perioperative period - from the surgery starts till 30 days after surgery
statistical parameter of diagnostic and prognostic accuracy of the method under study
次要结局
未报告次要终点