Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease

NCT06880120 | Completed

• 1 other identifier: UZ-1-16-02-388-19
• Study Type: interventional
• Target: 1,534
• Locations: 1 country
• Sites: 1

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))

Keywords

coronary artery disease; Seismocardiography; CardioClin

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection

  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).

  Baseline (Day 1, before standard diagnostic procedures).

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Heart Force Medical Inc.: lead

Study Sites (1)

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

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: May 19, 2021
• Primary Completion: October 19, 2021
• Study Completion: November 28, 2021
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

UZ (1)