Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease (HF-CAD)

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) Diagnostic Testing

Study type: Interventional

Funder types: Industry

Identifiers

NCT06880120

UZ-1-16-02-388-19

Details and patient eligibility

About

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.

Enrollment: 1,534 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18 years or older.
• Suspected CAD, based on clinical evaluation.
• Able to provide informed consent.

Exclusion criteria

• 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).

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,534 participants in 1 patient group

Evaluation of the CardioClin SCG/GCG Device for Coronary Artery Disease Diagnosis

Experimental group

Description:

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.

Treatment:

Device: Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing