Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))HF-CAD-CCTANCT06880133
Expansion of SCG/GCG-Based CAD Sceering: Inclusion of Healthy Controls and CCTA Patients
A study testing Seismocardiography (SCG) and Gyrocardiography (GCG) Screening 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 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. Read more about this study
- Who is it for?
- Ages 40 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) Screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteUzbekistan
- Study dates
- 12 Nov 2021to 1 Feb 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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: 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
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.
Read more
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.
- Being tested
- Seismocardiography (SCG) and Gyrocardiography (GCG) Screening
- 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) ScreeningDevice
This intervention involves the use of SCG/GCG diagnostic testing, a radiation-free, non-invasive technique for assessing cardiac function. SCG/GCG utilizes high-precision accelerometers and gyroscopes to record and analyze cardiac-induced microvibrations on the chest.
Participants will undergo SCG/GCG testing before their scheduled coronary artery calcium computed tomography (CAC-CT) or coronary computed tomography angiography (CCTA). The study aims to evaluate the diagnostic performance of SCG/GCG in identifying CAD, particularly in hypertensive patients and those with mild CAD.
Data collected from SCG/GCG will be compared with CAC-CT and CCTA findings to determine its predictive value for CAD severity and coronary artery stenosis.
| Study group | Role | What they receive |
|---|---|---|
| SCG/GCG-Based CAD Screening with Healthy and CCTA Groups | Experimental | Participants in this arm will undergo seismocardiography (SCG) and gyrocardiography (GCG) testing to evaluate the diagnostic accuracy of these non-invasive methods in detecting coronary artery disease (CAD). SCG/GCG utilizes high-precision accelerometers and gyroscopes to measure cardiac-induced chest wall vibrations.
This study will include patients scheduled for CAC-CT or CCTA at the Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC). The primary goal is to determine whether SCG/GCG testing can predict CAD, particularly in patients with hypertension and mild or no CAD, by comparing SCG/GCG-derived data with standard imaging results.
Measurements will be performed before CAC-CT and CCTA in both supine and upright sitting positions to assess the effect of posture on SCG/GCG signals. Receives: Device: Seismocardiography (SCG) and Gyrocardiography (GCG) Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening performance of SCG/GCG for Coronary Artery Disease (CAD)
The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CCTA).
Measured: Baseline
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 start12 Nov 2021
- Primary completion26 Dec 2023
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 1,600 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
- NCT06880133
- Sponsor's protocol ID
- UZ-Control-CCTA-1-16-02-388-19
- Acronym
- HF-CAD-CCTA
- 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
- Individual data sharing
- No
Publications
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.
PubMed 31607951Dehkordi 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.
PubMed 31507437Dehkordi 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.
PubMed 32268315Dehkordi 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
- 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
- ClinicalTrials.gov ID
- NCT06880133
- Acronym / sponsor ID
- HF-CAD-CCTA / UZ-Control-CCTA-1-16-02-388-19
- Keywords
- coronary artery disease, Seismocardiography, CardioClin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Heart Force Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 1 Feb 2025 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCG/GCG-Based CAD Screening with Healthy and CCTA Groups | Experimental | Device: Seismocardiography (SCG) and Gyrocardiography (GCG) ScreeningParticipants in this arm will undergo seismocardiography (SCG) and gyrocardiography (GCG) testing to evaluate the diagnostic accuracy of these non-invasive methods in detecting coronary artery disease (CAD). SCG/GCG utilizes high-precision accelerometers and gyroscopes to measure cardiac-induced chest wall vibrations. This study will include patients scheduled for CAC-CT or CCTA at the Republic Specialized Scientific-Practical Medical Center of Cardiology (RSPCMCC). The primary goal is to determine whether SCG/GCG testing can predict CAD, particularly in patients with hypertension and mild or no CAD, by comparing SCG/GCG-derived data with standard imaging results. Measurements will be performed before CAC-CT and CCTA in both supine and upright sitting positions to assess the effect of posture on SCG/GCG signals. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
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) ScreeningThis intervention involves the use of SCG/GCG diagnostic testing, a radiation-free, non-invasive technique for assessing cardiac function. SCG/GCG utilizes high-precision accelerometers and gyroscopes to record and analyze cardiac-induced microvibrations on the chest. Participants will undergo SCG/GCG testing before their scheduled coronary artery calcium computed tomography (CAC-CT) or coronary computed tomography angiography (CCTA). The study aims to evaluate the diagnostic performance of SCG/GCG in identifying CAD, particularly in hypertensive patients and those with mild CAD. Data collected from SCG/GCG will be compared with CAC-CT and CCTA findings to determine its predictive value for CAD severity and coronary artery stenosis. | Device | SCG/GCG-Based CAD Screening with Healthy and CCTA Groups |
Primary outcome
Screening performance of SCG/GCG for Coronary Artery Disease (CAD)
Time frame: Baseline
The ability of Seismocardiography (SCG) and Gyrocardiography (GCG) testing to accurately detect coronary artery disease (CAD) compared to standard diagnostic methods (CCTA).
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.
- Results publication: PubMed 31607951Dehkordi 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.
- Results publication: PubMed 31507437Dehkordi 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.
- Results publication: PubMed 32268315Dehkordi 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.
- 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.
- Individual participant dataSharing planned: No
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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) Screening 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 7 inclusion and 7 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?
Screening performance of SCG/GCG for Coronary Artery Disease (CAD) (time frame: Baseline). 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 NCT06880133, which also lists 4 linked publications.
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.