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

NCT06880133 | Completed

• 1 other identifier: UZ-Control-CCTA-1-16-02-388-19
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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)

• Screening performance of SCG/GCG for Coronary Artery Disease (CAD)

  The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CCTA).

  Baseline

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Seismocardiography (SCG) and Gyrocardiography (GCG) Screening DEVICE

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.

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Force Medical Inc.: lead

Study Sites (1)

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

Tashkent, Uzbekistan

Location

Related Publications (3)

• Dehkordi P, Bauer EP, Tavakolian K, Zakeri V, Blaber AP, Khosrow-Khavar F. Identifying Patients With Coronary Artery Disease Using Rest and Exercise Seismocardiography. Front Physiol. 2019 Sep 24;10:1211. doi: 10.3389/fphys.2019.01211. eCollection 2019.

  PMID: 31607951 BACKGROUND

• Dehkordi P, Khosrow-Khavar F, Di Rienzo M, Inan OT, Schmidt SE, Blaber AP, Sorensen K, Struijk JJ, Zakeri V, Lombardi P, Shandhi MMH, Borairi M, Zanetti JM, Tavakolian K. Comparison of Different Methods for Estimating Cardiac Timings: A Comprehensive Multimodal Echocardiography Investigation. Front Physiol. 2019 Aug 22;10:1057. doi: 10.3389/fphys.2019.01057. eCollection 2019.

  PMID: 31507437 BACKGROUND

• Dehkordi P, Tavakolian K, Tadi MJ, Zakeri V, Khosrow-Khavar F. Investigating the estimation of cardiac time intervals using gyrocardiography. Physiol Meas. 2020 Jun 10;41(5):055004. doi: 10.1088/1361-6579/ab87b2.

  PMID: 32268315 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Interventions

Mass Screening

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)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

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: November 12, 2021
• Primary Completion: December 26, 2023
• Study Completion: February 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)