Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399328
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-18
Brief Title:
Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy
Sponsor:
Samara State Medical University
Organization:
Samara State Medical University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRUISERS
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 installationsThis 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 wasnt explored yet
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 installationsThis 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 wasnt 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
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 IBS 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
4 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
1 - without clinical manifestations of CHD with low calcium score and without plaques without signs of CHD
2 - without clinical manifestations of CHD with high calcium count presence of plaques and without stenosis subclinical CHD
3 -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
1 To study the features of Surface Enhanced Raman spectrum SERS depending on belonging to 1group without CHD 2group with subclinical CHD 3group with CHD
2 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
3 To propose a model of CHD risk stratification based on the obtained data
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 IBS 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
4 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
1 - without clinical manifestations of CHD with low calcium score and without plaques without signs of CHD
2 - without clinical manifestations of CHD with high calcium count presence of plaques and without stenosis subclinical CHD
3 -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
1 To study the features of Surface Enhanced Raman spectrum SERS depending on belonging to 1group without CHD 2group with subclinical CHD 3group with CHD
2 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
3 To propose a model of CHD risk stratification based on the obtained data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None