Coronary Atherosclerosis of Native Coronary ArteryCRUISERSNCT06399328
Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy
An observational study of Coronary Atherosclerosis of Native Coronary Artery, run by Samara State Medical University at 1 site in Russia.
Trial summary
In the modern population, mortality and disability from cardiovascular diseases is predominant and is realized as a major medical and social problem. The study of mechanisms of development of age-related diseases, such as coronary heart disease (CHD), has demonstrated multiple qualitative and quantitative changes of… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Atherosclerosis of Native Coronary Artery
- What is being tested?
- Surface Enhanced Raman Spectroscopy
- How many people
- 220 participants
- Where
- 1 siteRussia
- Study dates
- 15 Sep 2023to 15 Nov 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Investigators plan to include all patients who were clinically evaluated and underwent coronary artery MSCT within the last year, divided into groups: 1. Those with no cardiac pain at baseline and the diagnosis of CHD was not established before MSCT and was not confirmed by the MSCT result. Patients without any pain syndrome. 2. Those with initial cardiac pain considered as atypical angina pectoris but CHD not confirmed by MSCT. 3. Those in whom the initial cardiac pain was considered as atypical angina and the diagnosis of CHD was confirmed by MSCT. According to the results of MSCT CA, all included will be divided into a group without CHD (A group) and two groups with CHD(B and C groups)
Inclusion Criteria:men and women who underwent MSCT of coronary arteries (CA) within the last year with determination of Agatston index and coronary plaques/ stenoses from 30 to 65 years old without verified diagnosis of coronary heart disease. (220 patients).
- without cardiac pain
- with atypical angina pectoris.
- with typical angina pectoris .
- possibly with asymptomatic atherosclerosis of carotid and other peripheral arteries not subject to surgical treatment (degree of stenosis not more than 50%) Possible combination with known type 2 diabetes mellitus not requiring insulin therapy, with hypertension stages 1-2.
Exclusion Criteria:-absence of MSCT CA results; poor image quality.
- tachycardia, irregular heart rhythm
- known at the time of inclusion: Acute Coronary Syndrom, myocardial infarction,any form of verified CHD, operated for coronary atherosclerosis (PCI) peripheral arteries (carotid, renal, leg),stroke of any kind.
- established diagnosis or clinical signs of chronic heart failure.
- familial hypercholesterolemia (total cholesterol 7.5 mmol/L or more),
- Type 1 diabetes mellitus (DM) or type 2 DM requiring insulin therapy
- Creatinine 135 µmol/L or higher;
- oncologic diseases, cirrhosis ,
- obesity : body mass index (BMI) 35kg/m2 and above,
- anemia Hemoglobin below 110g/l,
- dementia disorders,
- absence of informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Regional Samara clinical hospital na V.D.Seredavin
Samara, Samara Oblast, 443095
About this study
Official title: Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy. Assessment of Technology for Early Subclinical Detection of Coronary Heart Disease Based on Serum Metabolic Shifts .
In the modern population, mortality and disability from cardiovascular diseases is predominant and is realized as a major medical and social problem. The study of mechanisms of development of age-related diseases, such as coronary heart disease (CHD), has demonstrated multiple qualitative and quantitative changes of metabolites in biological fluids of the body - blood, in the vascular wall, as well as in the tissues of vital organs. In routine clinical practice only about a dozen metabolic parameters are determined by standard laboratory methods.
The proposed approach belongs to a new scientific direction , wich development is aimed at individualization of approaches to risk stratification of cardiovascular diseases and their complications. The data obtained in this project will allow to create a base of medical knowledge about spectral characteristics of blood serum, which most fully reflect the metabolic profile associated with atherosclerosis of coronary arteries. Researchers offer so-called multiplex diagnostics when multiple parameters of a biological object obtained by serum biochemical analysis and optical scattering analysis are used. Recognition of this big data is possible only by methods of mathematical analysis, which can take into account the degree of deviations, their directionality in each point of the spectral characteristic.
Read more
Until recently, the standard setup for Raman light scattering studies had significant dimensions. The high cost of such installations made it difficult to widely use the method of optical spectroscopy for rapid analysis of medical objects. In recent years, the situation on the market of scientific instrumentation has changed radically, which allowed to significantly reduce and cheapen all components of Raman installations.This simplification and cheapening allows to bring optical research in medicine (optical biopsy) to a new level of use, directly into clinical laboratories.
Novelty: This area of research belongs to high-tech and is very little represented in Europe. The prospect of using Surface Enhanced Raman spectroscopy (SERS) to determine subclinical lesions of coronary arteries and for risk stratification of diseases associated with atherosclerosis is quite unique and wasn't explored yet.
Read the detailed description
Currently, multispiral computed tomography of coronary arteries (MSCT) is the most informative method for diagnosing subclinical CHD, as well as in symptomatic patients (gold standard method). Investigators are interested in including all patients who have undergone coronary artery MSCT within the last year, who will be divided into groups:
- Those with no cardiac pain at baseline and the diagnosis of CHD was not established before MSCT and was not confirmed by the MSCT result. Patients without any pain syndrome.
- Those with initial cardiac pain considered as atypical angina pectoris but IBS not confirmed by MSCT.
- Those in whom the initial cardiac pain was considered as atypical angina and the diagnosis of CHD was confirmed by MSCT.
- Those in whom the diagnosis of CHD was verified before MSCT and confirmed by MSCT.
According to the results of MSCT, all included will be divided into a group without CHD and two groups with CHD:
- - without clinical manifestations of CHD with low calcium score and without plaques (without signs of CHD)
- - without clinical manifestations of CHD with high calcium count, presence of plaques and without stenosis (subclinical CHD)
- -with clinical manifestations of CHD with high calcium count, plaques and stenoses of different degrees (clinical CHD).
Accordingly, the differences of Raman spectrum in these groups will be revealed, which will make it possible to determine the degree of coronary atherosclerosis severity and stratify cardiovascular risk with a certain accuracy based only on the blood serum spectrum. These data will undoubtedly be of high scientific and practical value. To our knowledge, no similar studies have been conducted in the world.
No additional invasive procedures are anticipated in this study. A single blood draw is performed from the catheter before contrast injection for MSCT using a certified technique.
Aim: To propose a technology for early diagnosis of CHD and cardiovascular risk stratification based on serum metabolic shifts determined by serum Raman spectroscopy.
Objectives:
- To study the features of Surface Enhanced Raman spectrum ( SERS) depending on belonging to 1)group without CHD; 2)group with subclinical CHD; 3)group with CHD.
- To determine the possibility of reliable division of patients into these groups using the model based on SERS and SERS model in combination with known clinical parameters using artificial intelligence methodology.
- To propose a model of CHD risk stratification based on the obtained data.
- Being tested
- Surface Enhanced Raman Spectroscopy
- Keywords
- Surface Enhances Raman Spectroscopy, Computer Tomography of coronary arteries, Calcium coronary score, cardiovascular risk stratification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Enhanced Raman SpectroscopyDiagnostic test
Spectral measurements of blood serum were performed on a silver nanoparticle substrate. Serum samples were collected and placed in sterile tubes with subsequent freezing at -18°C. Immediately before analysis, samples were thawed at room temperature. For spectral analysis, each 1.5 μL serum sample was applied to a substrate with a layer of silver nanoparticles and dried for 30 minutes. The spectral characteristics of serum were analyzed using an experimental bench consisting of a spectrometric system and a microscope (ADF U300, ADF, China). The spectra were excited in the near infrared range using a laser module with a center wavelength of 785 nm. Each of the obtained spectra represented a discrete set of 1700 parameters in the range of studied frequencies.
| Study group | Role | What they receive |
|---|---|---|
| A group (normal coronary arteries) | A group: no signs of coronary calcium (<75 percentile values of corresponding age and gender ) and no plaques (normal coronary arteries) Receives: Diagnostic Test: Surface Enhanced Raman Spectroscopy | |
| B group (subclinical coronary atherosclerosis, stage 1) | B group: coronary calcium >75 percentile of corresponding age and gender /or plaques on MSCT without stenosis Receives: Diagnostic Test: Surface Enhanced Raman Spectroscopy | |
| C group ( subclinical/clinically evident coronary atherosclerosis,stage 2) | C group: atherosclerotic plaques of coronary artery with stenosis 50% and more, with or without chest pain Receives: Diagnostic Test: Surface Enhanced Raman Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model for determination of normal (A) coronary anatomy, subclinical stage 1 (B)of atherosclerosis and stage 2 lesions on the base of surface enhanced Raman spectroscopy
Sensitivity and specificity will be calculated for models, discriminating status of coronary arteries on the basis of SERS. In a case of high model performance it would be possible to assess coronary lesions by serum samples only.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 Sep 2023
- Primary completion15 Sep 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Atherosclerosis of Native Coronary ArteryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Samara Regional Clinical Hospital V.D. Seredavin
- Responsible party
- Sponsor
- Investigators
- Petr A Lebedev, professor, Principal investigator, chief of therapy chair of professional education department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399328
- Sponsor's protocol ID
- ATSERS001
- Acronym
- CRUISERS
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy. Assessment of Technology for Early Subclinical Detection of Coronary Heart Disease Based on Serum Metabolic Shifts .
- ClinicalTrials.gov ID
- NCT06399328
- Acronym / sponsor ID
- CRUISERS / ATSERS001
- Keywords
- Surface Enhances Raman Spectroscopy, Computer Tomography of coronary arteries, Calcium coronary score, cardiovascular risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Collaborators
- Samara Regional Clinical Hospital V.D. Seredavin
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 3 May 2024 (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.
In the modern population, mortality and disability from cardiovascular diseases is predominant and is realized as a major medical and social problem. The study of mechanisms of development of age-related diseases, such as coronary heart disease (CHD), has demonstrated multiple qualitative and quantitative changes of metabolites in biological fluids of the body - blood, in the vascular wall, as well as in the tissues of vital organs. In routine clinical practice only about a dozen metabolic parameters are determined by standard laboratory methods.
The proposed approach belongs to a new scientific direction , wich development is aimed at individualization of approaches to risk stratification of cardiovascular diseases and their complications. The data obtained in this project will allow to create a base of medical knowledge about spectral characteristics of blood serum, which most fully reflect the metabolic profile associated with atherosclerosis of coronary arteries. Researchers offer so-called multiplex diagnostics when multiple parameters of a biological object obtained by serum biochemical analysis and optical scattering analysis are used. Recognition of this big data is possible only by methods of mathematical analysis, which can take into account the degree of deviations, their directionality in each point of the spectral characteristic.
Until recently, the standard setup for Raman light scattering studies had significant dimensions. The high cost of such installations made it difficult to widely use the method of optical spectroscopy for rapid analysis of medical objects. In recent years, the situation on the market of scientific instrumentation has changed radically, which allowed to significantly reduce and cheapen all components of Raman installations.This simplification and cheapening allows to bring optical research in medicine (optical biopsy) to a new level of use, directly into clinical laboratories.
Novelty: This area of research belongs to high-tech and is very little represented in Europe. The prospect of using Surface Enhanced Raman spectroscopy (SERS) to determine subclinical lesions of coronary arteries and for risk stratification of diseases associated with atherosclerosis is quite unique and wasn't explored yet.
Detailed description
Currently, multispiral computed tomography of coronary arteries (MSCT) is the most informative method for diagnosing subclinical CHD, as well as in symptomatic patients (gold standard method). Investigators are interested in including all patients who have undergone coronary artery MSCT within the last year, who will be divided into groups:
- Those with no cardiac pain at baseline and the diagnosis of CHD was not established before MSCT and was not confirmed by the MSCT result. Patients without any pain syndrome.
- Those with initial cardiac pain considered as atypical angina pectoris but IBS not confirmed by MSCT.
- Those in whom the initial cardiac pain was considered as atypical angina and the diagnosis of CHD was confirmed by MSCT.
- Those in whom the diagnosis of CHD was verified before MSCT and confirmed by MSCT.
According to the results of MSCT, all included will be divided into a group without CHD and two groups with CHD:
- - without clinical manifestations of CHD with low calcium score and without plaques (without signs of CHD)
- - without clinical manifestations of CHD with high calcium count, presence of plaques and without stenosis (subclinical CHD)
- -with clinical manifestations of CHD with high calcium count, plaques and stenoses of different degrees (clinical CHD).
Accordingly, the differences of Raman spectrum in these groups will be revealed, which will make it possible to determine the degree of coronary atherosclerosis severity and stratify cardiovascular risk with a certain accuracy based only on the blood serum spectrum. These data will undoubtedly be of high scientific and practical value. To our knowledge, no similar studies have been conducted in the world.
No additional invasive procedures are anticipated in this study. A single blood draw is performed from the catheter before contrast injection for MSCT using a certified technique.
Aim: To propose a technology for early diagnosis of CHD and cardiovascular risk stratification based on serum metabolic shifts determined by serum Raman spectroscopy.
Objectives:
- To study the features of Surface Enhanced Raman spectrum ( SERS) depending on belonging to 1)group without CHD; 2)group with subclinical CHD; 3)group with CHD.
- To determine the possibility of reliable division of patients into these groups using the model based on SERS and SERS model in combination with known clinical parameters using artificial intelligence methodology.
- To propose a model of CHD risk stratification based on the obtained data.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A group (normal coronary arteries) | – | Diagnostic Test: Surface Enhanced Raman SpectroscopyA group: no signs of coronary calcium (<75 percentile values of corresponding age and gender ) and no plaques (normal coronary arteries) |
| B group (subclinical coronary atherosclerosis, stage 1) | – | Diagnostic Test: Surface Enhanced Raman SpectroscopyB group: coronary calcium >75 percentile of corresponding age and gender /or plaques on MSCT without stenosis |
| C group ( subclinical/clinically evident coronary atherosclerosis,stage 2) | – | Diagnostic Test: Surface Enhanced Raman SpectroscopyC group: atherosclerotic plaques of coronary artery with stenosis 50% and more, with or without chest pain |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators plan to include all patients who were clinically evaluated and underwent coronary artery MSCT within the last year, divided into groups: 1. Those with no cardiac pain at baseline and the diagnosis of CHD was not established before MSCT and was not confirmed by the MSCT result. Patients without any pain syndrome. 2. Those with initial cardiac pain considered as atypical angina pectoris but CHD not confirmed by MSCT. 3. Those in whom the initial cardiac pain was considered as atypical angina and the diagnosis of CHD was confirmed by MSCT. According to the results of MSCT CA, all included will be divided into a group without CHD (A group) and two groups with CHD(B and C groups)
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 |
|---|---|---|
| Surface Enhanced Raman SpectroscopySpectral measurements of blood serum were performed on a silver nanoparticle substrate. Serum samples were collected and placed in sterile tubes with subsequent freezing at -18°C. Immediately before analysis, samples were thawed at room temperature. For spectral analysis, each 1.5 μL serum sample was applied to a substrate with a layer of silver nanoparticles and dried for 30 minutes. The spectral characteristics of serum were analyzed using an experimental bench consisting of a spectrometric system and a microscope (ADF U300, ADF, China). The spectra were excited in the near infrared range using a laser module with a center wavelength of 785 nm. Each of the obtained spectra represented a discrete set of 1700 parameters in the range of studied frequencies. | Diagnostic test | A group (normal coronary arteries), B group (subclinical coronary atherosclerosis, stage 1), C group ( subclinical/clinically evident coronary atherosclerosis,stage 2) |
Primary outcome
Model for determination of normal (A) coronary anatomy, subclinical stage 1 (B)of atherosclerosis and stage 2 lesions on the base of surface enhanced Raman spectroscopy
Time frame: 1 year
Sensitivity and specificity will be calculated for models, discriminating status of coronary arteries on the basis of SERS. In a case of high model performance it would be possible to assess coronary lesions by serum samples only.
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 16 Oct 2026.
- Khristoforova YA, Bratchenko LA, Skuratova MA, Lebedeva EA, Lebedev PA, Bratchenko IA. Raman spectroscopy in chronic heart failure diagnosis based on human skin analysis. J Biophotonics. 2023 Jul;16(7):e202300016. doi: 10.1002/jbio.202300016.Link provided by the sponsor.
- Bratchenko LA, Bratchenko IA, Khristoforova YA, Artemyev DN, Konovalova DY, Lebedev PA, Zakharov VP. Raman spectroscopy of human skin for kidney failure detection. J Biophotonics. 2021 Feb;14(2):e202000360. doi: 10.1002/jbio.202000360.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Petr A Lebedev, professor principal investigator
chief of therapy chair of professional education department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Atherosclerosis of Native Coronary Artery, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Oct 2026. 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 Russia. 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?
Model for determination of normal (A) coronary anatomy, subclinical stage 1 (B)of atherosclerosis and stage 2 lesions on the base of surface enhanced Raman spectroscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.