Improvement of Diagnostic Accuracy of Seismocardiography and Gyrocardiography for Non-Invasive Coronary Artery Disease Diagnosis: A 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
- 1,534
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection
研究概览
简要总结
This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG). These techniques measure small vibrations on the chest caused by the heartbeat using highly sensitive sensors. The goal is to determine whether this method, using the CardioClin device, can accurately detect CAD compared to standard tests like coronary calcium scans (CAC-CT), CT angiography (CCTA), and invasive coronary angiography (ICA).
Patients who are already scheduled for one of these standard tests will also undergo SCG/GCG testing. The study will compare results to see if the new method provides a reliable, cost-effective, and radiation-free alternative for diagnosing CAD.
This research could help improve early detection of heart disease without the need for invasive procedures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older.
- •Suspected CAD, based on clinical evaluation.
- •Able to provide informed consent.
排除标准
- •Pregnant or breastfeeding women.
- •Presence of implanted cardiac devices (e.g., pacemakers, implantable cardioverter defibrillators) that may interfere with SCG/GCG signal acquisition.
- •Severe arrhythmias that may affect signal interpretation.
- •Inability to maintain required testing positions (supine and sitting).
- •Medical conditions preventing informed consent (e.g., severe cognitive impairment).
研究组 & 干预措施
Evaluation of the CardioClin SCG/GCG Device for Coronary Artery Disease Diagnosis
Participants in this arm will undergo seismocardiography (SCG) and gyrocardiography (GCG) testing using the CardioClin device, a non-invasive diagnostic tool designed to assess coronary artery disease (CAD). The device uses high-precision accelerometers and gyroscopic sensors to measure the mechanical vibrations of the heart.
All participants are already scheduled for standard diagnostic procedures such as coronary artery calcium computed tomography (CAC-CT), coronary computed tomography angiography (CCTA), or invasive coronary angiography (ICA). SCG/GCG testing will be performed before these standard procedures, with measurements taken in both supine and sitting positions.
The goal is to compare the diagnostic accuracy of CardioClin SCG/GCG recordings against traditional imaging methods to assess its potential as a non-invasive alternative for CAD detection.
干预措施: Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing (Device)
结局指标
主要结局
Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection
时间窗: Baseline (Day 1, before standard diagnostic procedures).
The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CAC-CT, CCTA, ICA).
次要结局
未报告次要终点