Evaluation and Improvement of Diagnostic Accuracy of Seismocardiography and Gyrocardiography for Non-Invasive Coronary Artery Disease Diagnosis in Comparison with Coronary Artery Calcium Computed Tomography, Coronary Computed Tomography Angiography, and Invasive Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Screening performance of SCG/GCG for Coronary Artery Disease (CAD)
研究概览
简要总结
This study evaluates a new, non-invasive method for screening coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG). These techniques measure chest vibrations caused by heart activity using highly sensitive sensors.
Participants include patients with known or suspected CAD, as well as healthy individuals and those undergoing coronary computed tomography angiography (CCTA). The goal is to determine whether SCG/GCG testing can accurately differentiate between individuals with significant and non-significant coronary artery stenosis.
SCG/GCG testing will be conducted before standard diagnostic procedures, including coronary artery calcium computed tomography (CAC-CT) and CCTA. The results will be analyzed to compare the performance of this novel method with existing imaging techniques.
This research aims to provide a non-invasive, cost-effective alternative for screening CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40 years or older.
- •Electively scheduled for CAC-CT and have an indication for CCTA
- •Suspected coronary artery disease (CAD) based on the presence of:
- •At least two cardiovascular risk factors (e.g., hypertension, smoking, diabetes, dyslipidemia, obesity).
- •CAD-related symptoms (e.g., chest pain, dyspnea on exertion).
- •Suspected congenital coronary abnormalities.
- •Ability to provide informed consent.
排除标准
- •Severe cardiac arrhythmias that may interfere with SCG/GCG recordings.
- •Decompensated heart failure or severe valvular heart disease.
- •Other clinically significant concomitant diseases that may impact study participation.
- •History of heart surgery (e.g., recent CABG, valve replacement) that alters chest wall dynamics.
- •Contraindications for undergoing CAC-CT or CCTA (e.g., severe renal insufficiency preventing contrast use).
- •Inability to remain still in supine or upright sitting positions for testing.
- •Inability to provide informed consent due to cognitive or neurological conditions.
结局指标
主要结局
Screening performance of SCG/GCG for Coronary Artery Disease (CAD)
时间窗: Baseline
The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CCTA).
次要结局
未报告次要终点