Status:

COMPLETED

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

Lead Sponsor:

Heart Force Medical Inc.

Conditions:

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

Eligibility:

All Genders

40+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 12 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2025

Estimated Enrollment :

1600 Patients enrolled

Trial Details

Trial ID

NCT06880133

Start Date

November 12 2021

End Date

February 1 2025

Last Update

March 17 2025

Active Locations (1)

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

Tashkent, Uzbekistan