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OpenTrials
Completed

NCT Number: NCT06880120

Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease

This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG). These techniques measure small vibrations on the chest caused by the heartbeat using highly sensitive sensors. The goal is to determine whether this method, using the CardioClin device, can accurately detect CAD compared to standard tests like coronary calcium scans (CAC-CT), CT angiography (CCTA), and invasive coronary angiography (ICA).

Patients who are already scheduled for one of these standard tests will also undergo SCG/GCG testing. The study will compare results to see if the new method provides a reliable, cost-effective, and radiation-free alternative for diagnosing CAD.

This research could help improve early detection of heart disease without the need for invasive procedures.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years or older.
  • Suspected CAD, based on clinical evaluation.
  • Able to provide informed consent.

Exclusion criteria

  • Pregnant or breastfeeding women.
  • Presence of implanted cardiac devices (e.g., pacemakers, implantable cardioverter defibrillators) that may interfere with SCG/GCG signal acquisition.
  • Severe arrhythmias that may affect signal interpretation.
  • Inability to maintain required testing positions (supine and sitting).
  • Medical conditions preventing informed consent (e.g., severe cognitive impairment).

Treatment and study plan

Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing

Device

This intervention involves the use of Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing, a non-invasive technique that records mechanical vibrations of the chest caused by heart activity using high-precision accelerometers and gyroscopes. Unlike traditional imaging techniques such as coronary artery calcium computed tomography (CAC-CT), coronary computed tomography angiography (CCTA), and invasive coronary angiography (ICA), this method does not require radiation exposure (unlike CAC-CT and CCTA), is completely non-invasive and does not require contrast agents (unlike ICA), and provides real-time cardiac mechanical activity measurements rather than anatomical imaging.

Primary outcomes

  1. Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection

    Time frame: Baseline (Day 1, before standard diagnostic procedures).

    The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CAC-CT, CCTA, ICA).

Sponsors and collaborators

Lead sponsor

Heart Force Medical Inc.

Industry

Registry information

Official study title

Improvement of Diagnostic Accuracy of Seismocardiography and Gyrocardiography for Non-Invasive Coronary Artery Disease Diagnosis: A Comparison With Coronary Artery Calcium Computed Tomography, Coronary Computed Tomography Angiography, and Invasive Coronary Angiography

Acronym: HF-CAD

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
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.

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