Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease

NCT ID: NCT06880120

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2021-11-28

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing

Intervention Type: DEVICE

This intervention involves the use of Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing, a non-invasive technique that records mechanical vibrations of the chest caused by heart activity using high-precision accelerometers and gyroscopes. Unlike traditional imaging techniques such as coronary artery calcium computed tomography (CAC-CT), coronary computed tomography angiography (CCTA), and invasive coronary angiography (ICA), this method does not require radiation exposure (unlike CAC-CT and CCTA), is completely non-invasive and does not require contrast agents (unlike ICA), and provides real-time cardiac mechanical activity measurements rather than anatomical imaging.

Interventions

Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing

This intervention involves the use of Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing, a non-invasive technique that records mechanical vibrations of the chest caused by heart activity using high-precision accelerometers and gyroscopes. Unlike traditional imaging techniques such as coronary artery calcium computed tomography (CAC-CT), coronary computed tomography angiography (CCTA), and invasive coronary angiography (ICA), this method does not require radiation exposure (unlike CAC-CT and CCTA), is completely non-invasive and does not require contrast agents (unlike ICA), and provides real-time cardiac mechanical activity measurements rather than anatomical imaging.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heart Force Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC)

Tashkent, , Uzbekistan

Countries

Uzbekistan

Other Identifiers

UZ-1-16-02-388-19

Identifier Type: -

Identifier Source: org_study_id