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

March 14, 2025 updated by: Heart Force Medical Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uzbekistan
      • Tashkent, Uzbekistan
        • Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection
Time Frame: 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).
Baseline (Day 1, before standard diagnostic procedures).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Force Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

November 28, 2021

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZ-1-16-02-388-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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