Screening for Significant Coronary Artery Stenosis Using Single-channel Electrocardiogram Analysis With Artificial Intelligence Elements
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
It is a prospective, controlled, single-center, non-randomized, observational study. Two patient groups are planned for inclusion: the first - 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results; the second - a control group consisting of 200 patients without significant stenosis according to CAG or MSCT data.
All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion.
Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as indicated.
All patients included in the study will undergo ECG recording within 1 month before or after CAG or MSCT in standard lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform.
The result of this study will be the identification of ECG parameters that correlate with significant coronary artery stenosis.
详细描述
The aim of the study:: To develop and evaluate the diagnostic efficacy of a screening method for significant coronary artery stenosis based on data obtained from the analysis of a single-channel electrocardiogram.
This is a prospective, controlled, single-center, non-randomized, observational study. Two patient groups are planned for inclusion: the first group comprises 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results; the second group is a control group consisting of 200 patients without significant stenosis according to CAG or MSCT data.
All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion. Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as clinically indicated. ECG registration in standard lead I will be performed within 3 months before or after the CAG or MSCT.
Obtained data will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform.
The single-channel ECG will be recorded using the portable single-lead ECG monitor CardioQvark. It is designed as an iPhone cover. It is registered with the Federal Service for Health Surveillance on February 15, 2019. RZN No. 2019/8124.
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
- •Presence of written informed consent from the patient to participate in the study.
- •Age 18 years and older.
- •Outpatient visit and/or hospitalization at the research center with coronary visualization performed.
- •Non-inclusion criteria:
- •Absence of sufficient data on coronary anatomy and stenosis significance.
- •Any conditions impairing the quality of single-channel ECG recording (Parkinson's disease, essential tremor, and others).
- •Absence of written informed consent from the patient to participate in the study.
排除标准
- •Patient's unwillingness to continue participation in the study.
- •Inability to perform full analysis of single-channel ECG digital characteristics.
- •Refusal of coronary visualization methods for any reason.