Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy
CRUISERS
1 other identifier
observational
220
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2023
CompletedFirst Submitted
Initial submission to the registry
April 18, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2025
CompletedMay 3, 2024
April 1, 2024
2 years
April 18, 2024
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (3)
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)
B group (subclinical coronary atherosclerosis, stage 1)
B 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)
C group: atherosclerotic plaques of coronary artery with stenosis 50% and more, with or without chest pain
Interventions
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.
Eligibility Criteria
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)
You may qualify if:
- 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.
You may not qualify if:
- tachycardia, irregular heart rhythm
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regional Samara clinical hospital na V.D.Seredavin
Samara, Samara Oblast, 443095, Russia
Related Links
- 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.
- 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.
Biospecimen
Serum samples 2 ml of each person for SERS evaluation
Study Officials
- PRINCIPAL INVESTIGATOR
Petr A Lebedev, professor
chief of therapy chair of professional education department
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2024
First Posted
May 3, 2024
Study Start
September 15, 2023
Primary Completion
September 15, 2025
Study Completion
November 15, 2025
Last Updated
May 3, 2024
Record last verified: 2024-04