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 .

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Russian Federation
Regional Samara clinical hospital na V.D.Seredavin
RECRUITING
Samara
Contact Information
Primary
Petr Lebedev, professor
palebedev@yahoo.com
+7927-260-20-24
Backup
Maria Skuratova, PhD
skuratova_m@mail.ru
+7937-990-41-48
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2025-11-15
Participants
Target number of participants: 220
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Samara Regional Clinical Hospital V.D. Seredavin
Leads: Samara State Medical University

This content was sourced from clinicaltrials.gov