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NCT06880133Completed

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

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

Source: ClinicalTrials.gov · Last updated 17 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1600 (actual)
First submitted
11 Mar 2025
Start date
12 Nov 2021
Primary completion date
26 Dec 2023
Lead sponsor
Heart Force Medical Inc.
NCT number
NCT06880133

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1600
  • From 12 Nov 2021 to the primary completion date, 26 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other clinically significant concomitant diseases that may impact study participation.

Other illness

  • Severe cardiac arrhythmias that may interfere with SCG/GCG recordings.
  • Decompensated heart failure or severe valvular heart disease.
  • 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 provide informed consent due to cognitive or neurological conditions.

Other

  • Inability to remain still in supine or upright sitting positions for testing.

Who the study is looking for

  • 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.

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC)
Coordinator of this site? Confirm its status
TashkentUzbekistanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.