Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
Prediction of Outcomes in Patients With Chronic Heart Failure Based on Tissue Raman Spectroscopy
Sponsor:
Samara State Medical University
Organization:
Samara State Medical University
Study Overview
Official Title:
Prediction of Outcomes in Patients With Chronic Heart Failure Based on Tissue Raman Spectroscopy
Status:
ACTIVE_NOT_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:
PROMETHEUS
Brief Summary:
Chronic heart failure CHF is a syndrome complicating heart disease the prevalence of which has reached epidemic levels According to global statistics the most common causes of CHF are coronary heart disease CHD 265 arterial hypertension AH262 The category of patients with CHD complicated by CHF prevails in clinical practice requiring an optimized approach to determining prognosis in order to improve the effectiveness of therapy In the literature this issue has been studied with the use of general clinical biochemical instrumental criteria Nevertheless the problem of optimized prognosis in patients with CHF remains Its solution may lie in the study of metabolic parameters of biological media - skin blood serum by Raman spectroscopy
Skin is an accessible tissue for studying the effects of a wide range of age-dependent noncommunicable diseases including cardiovascular disease type 2 diabetes mellitus and chronic kidney disease We were one of the first to use skin RS as a method of determining renal dysfunction a necessary component of chronic kidney disease However the applicability of RSSERS in the diagnosis and prognosis of specific diseases as well as in the collection of statistical data for this analytical approach remains an open question Despite the fact that the method is classified as analytical it can be used to identify not so much specific chemical molecules as their specific loci which provide vibrations that change the wavelengths of the scattered spectrum The resulting spectrum can be presented as a metabolic portrait of the disease with the most informative loci the combination of which is associated with a negative prognosis
The innovative analytical methods of optical spectroscopy proposed in this project provide new level information about hundreds of molecules and their active centers that have prospects as biomarkers This study aims to determine the clinical relevance of skin and serum RS in patients with CHF realized on state-of-the-art instrumentation in a comprehensive patient study setting The research proposed in this project will contribute to the development of high-tech production of new optical devices for rapid diagnosis and prognosis of a wide range of diseases
Skin is an accessible tissue for studying the effects of a wide range of age-dependent noncommunicable diseases including cardiovascular disease type 2 diabetes mellitus and chronic kidney disease We were one of the first to use skin RS as a method of determining renal dysfunction a necessary component of chronic kidney disease However the applicability of RSSERS in the diagnosis and prognosis of specific diseases as well as in the collection of statistical data for this analytical approach remains an open question Despite the fact that the method is classified as analytical it can be used to identify not so much specific chemical molecules as their specific loci which provide vibrations that change the wavelengths of the scattered spectrum The resulting spectrum can be presented as a metabolic portrait of the disease with the most informative loci the combination of which is associated with a negative prognosis
The innovative analytical methods of optical spectroscopy proposed in this project provide new level information about hundreds of molecules and their active centers that have prospects as biomarkers This study aims to determine the clinical relevance of skin and serum RS in patients with CHF realized on state-of-the-art instrumentation in a comprehensive patient study setting The research proposed in this project will contribute to the development of high-tech production of new optical devices for rapid diagnosis and prognosis of a wide range of diseases
Detailed Description:
This study included participants hospitalized in the cardiology unit of Samara city Clinical Hospital No1 na NIPirogov of Emergency Medical AidThe reason for hospitalization was newly diagnosed chronic heart failure or its exacerbation
Objective 1 to develop a personalized approach to prediction of total mortality cardiovascular death in patients with CHD complicated by CHF on the basis of Raman spectra of skin plasma blood serum
2To develop a classification of Raman spectra characteristic for CHF as well as its phenotypes and relevant comorbid conditions - Chronic kidney disease CKD and glycemic status
Study Material
1 Group with CHF based on CHD of both sexes aged 35 to 84 years 200 participants
2 Group with CHD without CHF 70 participants
3 Group with CHF with non-ischemic cardiomyopathies 50 participants
4 group with CHF and valvular cardiomyopathies 40 participants
The study design is divided into two consecutive parts
Across-sectional cohort Bprospective
Cross-sectional study part 1 Material groups 1-4
Objectives
1 To identify Raman spectral characteristics specific to the CHF syndrome skin RS and serum SERS would be performed in groups of different CHF etiology noncomplicated CHD CHD complicated by CHF non-ischemic Cardiomyopathies CMP complicated by CHFDilated CMP Inflammatory CMP valvular CMPs
2 To study the influence of CHF phenotypes divided by Left Ventricular ejection fraction LVEF as well as comorbidity - chronic kidney disease type 2 diabetes mellitusDM2 on skin and serum Raman spectra biochemical parameters in the group with CHD
Prospective study part 2 Study material group 1
Objectives
3 To establish the possibilities of serum SERS and skin RS parameters in predicting overall mortality in patients with CHD complicated by CHF in comparison with prediction models based on parameters of clinical biochemical and instrumental routine techniques
4 Develop prediction models for total mortality CV mortality and CV mortality in combination with hospitalizations for CHD participants with CHF
5 To establish relationships with the most prognostically important spectral components of RS and known markers of atherosclerosis and cardiovascular diseases CVD CKD parameters troponin T glucose cholesterol spectrum parameters
Planned period of the cross-sectional phase of the study November 2022 to May 2023
Visit 1- Determination of inclusionexclusion criteria for recruitment Collection of clinical biochemical instrumental parameters Determination of serum SERS and skin RS
Planned period of the prospective study November 2022-May 2024 Visit -1 is used to include only participants from group 1 in the prospective part of the study CHDCHF
Visit-2 is planned at 4-6 months after the initial evaluation The aim of visit-to assess patients clinical status and compliance to prescribed medication
Visit 3 end of prospective follow-up The purpose of the visit - to collect information about hospitalizations and complications that occurred after visit 2 In case of death according to relatives information to confirm the fact of death in the electronic medical information analytical system EMIAS
Scientific novelty of the research The technology of surface enhanced Raman spectroscopy SERS of blood serum on nanosilver substrate will be tested Artificial intelligence technology is used for discriminative analysis based on SERS parameters
Spectral features due to the influence of CVD diabetes mellitus and renal dysfunction will be specified on RS of skin and serum SERS highlighted for the first time
For the first time the RS of skin serum of non-ischemic CMPs and valvular CMPs is studied
For the first time a prognostic model using skin RS SERS of patients with CHD complicated by CHF is proposed
Based on the results of the study models will be developed to predict mortality and cardiovascular complications in patients with CHD complicated by CHF
Expected Results
Mathematical models will be developed to predict cumulative mortality CV mortality and cumulative target including CV mortality and hospitalizations for exacerbations of CHF based on independent predictors of biochemical clinical skin and serum Raman spectrometry parameters
Spectral regions reflecting the influence of chronic heart failure syndrome as such will be identified by comparing serum SERS of patients with different etiologies of CHF
Spectral characteristics of three phenotypes of CHF will be identified with preserved LVEF moderately reduced LVEF low LVEF
Spectral characteristics specific for chronic kidney disease and DM2 will be identified
Objective 1 to develop a personalized approach to prediction of total mortality cardiovascular death in patients with CHD complicated by CHF on the basis of Raman spectra of skin plasma blood serum
2To develop a classification of Raman spectra characteristic for CHF as well as its phenotypes and relevant comorbid conditions - Chronic kidney disease CKD and glycemic status
Study Material
1 Group with CHF based on CHD of both sexes aged 35 to 84 years 200 participants
2 Group with CHD without CHF 70 participants
3 Group with CHF with non-ischemic cardiomyopathies 50 participants
4 group with CHF and valvular cardiomyopathies 40 participants
The study design is divided into two consecutive parts
Across-sectional cohort Bprospective
Cross-sectional study part 1 Material groups 1-4
Objectives
1 To identify Raman spectral characteristics specific to the CHF syndrome skin RS and serum SERS would be performed in groups of different CHF etiology noncomplicated CHD CHD complicated by CHF non-ischemic Cardiomyopathies CMP complicated by CHFDilated CMP Inflammatory CMP valvular CMPs
2 To study the influence of CHF phenotypes divided by Left Ventricular ejection fraction LVEF as well as comorbidity - chronic kidney disease type 2 diabetes mellitusDM2 on skin and serum Raman spectra biochemical parameters in the group with CHD
Prospective study part 2 Study material group 1
Objectives
3 To establish the possibilities of serum SERS and skin RS parameters in predicting overall mortality in patients with CHD complicated by CHF in comparison with prediction models based on parameters of clinical biochemical and instrumental routine techniques
4 Develop prediction models for total mortality CV mortality and CV mortality in combination with hospitalizations for CHD participants with CHF
5 To establish relationships with the most prognostically important spectral components of RS and known markers of atherosclerosis and cardiovascular diseases CVD CKD parameters troponin T glucose cholesterol spectrum parameters
Planned period of the cross-sectional phase of the study November 2022 to May 2023
Visit 1- Determination of inclusionexclusion criteria for recruitment Collection of clinical biochemical instrumental parameters Determination of serum SERS and skin RS
Planned period of the prospective study November 2022-May 2024 Visit -1 is used to include only participants from group 1 in the prospective part of the study CHDCHF
Visit-2 is planned at 4-6 months after the initial evaluation The aim of visit-to assess patients clinical status and compliance to prescribed medication
Visit 3 end of prospective follow-up The purpose of the visit - to collect information about hospitalizations and complications that occurred after visit 2 In case of death according to relatives information to confirm the fact of death in the electronic medical information analytical system EMIAS
Scientific novelty of the research The technology of surface enhanced Raman spectroscopy SERS of blood serum on nanosilver substrate will be tested Artificial intelligence technology is used for discriminative analysis based on SERS parameters
Spectral features due to the influence of CVD diabetes mellitus and renal dysfunction will be specified on RS of skin and serum SERS highlighted for the first time
For the first time the RS of skin serum of non-ischemic CMPs and valvular CMPs is studied
For the first time a prognostic model using skin RS SERS of patients with CHD complicated by CHF is proposed
Based on the results of the study models will be developed to predict mortality and cardiovascular complications in patients with CHD complicated by CHF
Expected Results
Mathematical models will be developed to predict cumulative mortality CV mortality and cumulative target including CV mortality and hospitalizations for exacerbations of CHF based on independent predictors of biochemical clinical skin and serum Raman spectrometry parameters
Spectral regions reflecting the influence of chronic heart failure syndrome as such will be identified by comparing serum SERS of patients with different etiologies of CHF
Spectral characteristics of three phenotypes of CHF will be identified with preserved LVEF moderately reduced LVEF low LVEF
Spectral characteristics specific for chronic kidney disease and DM2 will be identified
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