|

Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy

RECRUITINGSponsored by Samara State Medical University
Actively Recruiting
SponsorSamara State Medical University
Started2023-09-15
Est. completion2025-09-15
Eligibility
Age30 Years – 65 Years
Healthy vol.Accepted

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

Age: 30 Years – 65 YearsHealthy volunteers accepted
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.

Conditions2

Coronary Atherosclerosis of Native Coronary ArteryHeart Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.