Clinical trial NCT06880133: Expansion of SCG/GCG-Based CAD Sceering: Inclusion of Healthy Controls and CCTA Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Keywords: coronary artery disease
Seismocardiography
CardioClin
Lead sponsor: Heart Force Medical Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-17
Enrollment: 1600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Screening performance of SCG/GCG for Coronary Artery Disease (CAD)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC)
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.