Expansion of SCG/GCG-Based CAD Sceering: Inclusion of Healthy Controls and CCTA Patients (HF-CAD-CCTA)

Heart Force Medical

Status: Completed

Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Treatments: Device: Seismocardiography (SCG) and Gyrocardiography (GCG) Screening

Study type: Interventional

Funder types: Industry

Identifiers

NCT06880133

UZ-Control-CCTA-1-16-02-388-19

Details and patient eligibility

About

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.

Enrollment: 1,600 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,600 participants in 1 patient group

SCG/GCG-Based CAD Screening with Healthy and CCTA Groups

Experimental group

Description:

Participants in this arm will undergo seismocardiography (SCG) and gyrocardiography (GCG) testing to evaluate the diagnostic accuracy of these non-invasive methods in detecting coronary artery disease (CAD). SCG/GCG utilizes high-precision accelerometers and gyroscopes to measure cardiac-induced chest wall vibrations. This study will include patients scheduled for CAC-CT or CCTA at the Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC). The primary goal is to determine whether SCG/GCG testing can predict CAD, particularly in patients with hypertension and mild or no CAD, by comparing SCG/GCG-derived data with standard imaging results. Measurements will be performed before CAC-CT and CCTA in both supine and upright sitting positions to assess the effect of posture on SCG/GCG signals.

Treatment:

Device: Seismocardiography (SCG) and Gyrocardiography (GCG) Screening