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

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.

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Key information

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tashkent, Uzbekistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Heart Force Medical Inc.

Industry

Registry information

Official study title

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

Acronym: HF-CAD-CCTA

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2025
First posted: Mar 17, 2025
Registry last updated: Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed