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

March 11, 2025 updated by: Heart Force Medical Inc.

Evaluation and Improvement of Diagnostic Accuracy of Seismocardiography and Gyrocardiography for Non-Invasive Coronary Artery Disease Diagnosis in Comparison with Coronary Artery Calcium Computed Tomography, Coronary Computed Tomography Angiography, and Invasive Coronary Angiography

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1600

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:

  • 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.

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

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

This intervention involves the use of SCG/GCG diagnostic testing, a radiation-free, non-invasive technique for assessing cardiac function. SCG/GCG utilizes high-precision accelerometers and gyroscopes to record and analyze cardiac-induced microvibrations on the chest.

Participants will undergo SCG/GCG testing before their scheduled coronary artery calcium computed tomography (CAC-CT) or coronary computed tomography angiography (CCTA). The study aims to evaluate the diagnostic performance of SCG/GCG in identifying CAD, particularly in hypertensive patients and those with mild CAD.

Data collected from SCG/GCG will be compared with CAC-CT and CCTA findings to determine its predictive value for CAD severity and coronary artery stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening performance of SCG/GCG for Coronary Artery Disease (CAD)
Time Frame: Baseline
The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CCTA).
Baseline

Collaborators and Investigators

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

Sponsor

Heart Force Medical Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 12, 2021

Primary Completion (Actual)

December 26, 2023

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 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 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZ-Control-CCTA-1-16-02-388-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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