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

Heart Force Medical Inc.1,600 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,600

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Interventions

Seismocardiography (SCG) and Gyrocardiography (GCG) ScreeningDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline