Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))HF-CADNCT06880120
Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease
A study testing Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Heart Force Medical Inc. at 1 site in Uzbekistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
- What is being tested?
- Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,534 participants
- Where
- 1 siteUzbekistan
- Study dates
- 19 May 2021to 28 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Suspected CAD, based on clinical evaluation.
- Able to provide informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC)
Tashkent
About this study
Official 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
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.
- Being tested
- Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing
- Keywords
- coronary artery disease, Seismocardiography, CardioClin
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic TestingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of the CardioClin SCG/GCG Device for Coronary Artery Disease Diagnosis | Experimental | Participants in this arm will undergo seismocardiography (SCG) and gyrocardiography (GCG) testing using the CardioClin device, a non-invasive diagnostic tool designed to assess coronary artery disease (CAD). The device uses high-precision accelerometers and gyroscopic sensors to measure the mechanical vibrations of the heart.
All participants are already scheduled for standard diagnostic procedures such as coronary artery calcium computed tomography (CAC-CT), coronary computed tomography angiography (CCTA), or invasive coronary angiography (ICA). SCG/GCG testing will be performed before these standard procedures, with measurements taken in both supine and sitting positions.
The goal is to compare the diagnostic accuracy of CardioClin SCG/GCG recordings against traditional imaging methods to assess its potential as a non-invasive alternative for CAD detection. Receives: Device: Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection
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).
Measured: Baseline (Day 1, before standard diagnostic procedures).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start19 May 2021
- Primary completion19 Oct 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Force Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880120
- Sponsor's protocol ID
- UZ-1-16-02-388-19
- Acronym
- HF-CAD
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dehkordi P, Tavakolian K, Rocco T, Fozilov K, Yuldashov A, Zareba W, Yuldashov B, Atamuratov B, Marateb HR, Doniyorov S, Kurbanova B, Khosrow-Khavar F. Electro-mechanical risk score for coronary artery disease risk estimation using seismocardiography. Eur Heart J Digit Health. 2026 Sep 4;7(8):ztag139. doi: 10.1093/ehjdh/ztag139. eCollection 2026 Oct.
PubMed 42712931
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06880120
- Acronym / sponsor ID
- HF-CAD / UZ-1-16-02-388-19
- Keywords
- coronary artery disease, Seismocardiography, CardioClin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,534 participants (actual)
- Lead sponsor
- Heart Force Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the CardioClin SCG/GCG Device for Coronary Artery Disease Diagnosis | Experimental | Device: Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic TestingParticipants in this arm will undergo seismocardiography (SCG) and gyrocardiography (GCG) testing using the CardioClin device, a non-invasive diagnostic tool designed to assess coronary artery disease (CAD). The device uses high-precision accelerometers and gyroscopic sensors to measure the mechanical vibrations of the heart. All participants are already scheduled for standard diagnostic procedures such as coronary artery calcium computed tomography (CAC-CT), coronary computed tomography angiography (CCTA), or invasive coronary angiography (ICA). SCG/GCG testing will be performed before these standard procedures, with measurements taken in both supine and sitting positions. The goal is to compare the diagnostic accuracy of CardioClin SCG/GCG recordings against traditional imaging methods to assess its potential as a non-invasive alternative for CAD detection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older.
- Suspected CAD, based on clinical evaluation.
- Able to provide informed consent.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic TestingThis 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. | Device | Evaluation of the CardioClin SCG/GCG Device for Coronary Artery Disease Diagnosis |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 42712931Dehkordi P, Tavakolian K, Rocco T, Fozilov K, Yuldashov A, Zareba W, Yuldashov B, Atamuratov B, Marateb HR, Doniyorov S, Kurbanova B, Khosrow-Khavar F. Electro-mechanical risk score for coronary artery disease risk estimation using seismocardiography. Eur Heart J Digit Health. 2026 Sep 4;7(8):ztag139. doi: 10.1093/ehjdh/ztag139. eCollection 2026 Oct.
Related trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Not yet recruiting
TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Chronic Heart Failure
Active, not recruiting
Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program
Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
RecruitingObservational study
REGistry of Long-term AnTithrombotic TherApy-1
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Peripheral Artery Disease
Not yet recruiting
Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Heart Force Medical Inc. at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of SCG/GCG for Coronary Artery Disease (CAD) Detection (time frame: Baseline (Day 1, before standard diagnostic procedures).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.