Prediction of Outcomes in Patients With Chronic Heart Failure Based on Tissue Raman Spectroscopy

NCT06393595 | Completed DMC

• 1 other identifier: CHF-RS001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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): 26.5%, arterial hypertension (AH):26.2% . 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 RS/SERS 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.

Conditions

Chronic Heart Failure

Keywords

cumulative death; cardiovascular death (CVD); CVD or hospitalization for heart failure exacerbation; surface enhanced Raman Spectroscopy; skin Raman Spectroscopy

Outcome Measures

Primary Outcomes (2)

• record in electronic medical information analitical system(EMIAS)

  The initial information of participant's death would be verified by official record

  01.11.2022-01.05.2024

• record in electronic medical information analitical system (EMIAS)

  The initial information of participant's cardiovascular death would be verified by official record

  01/11/2022-01/05/2024

Secondary Outcomes (1)

• record in electronic medical information analitical system (EMIAS) and history of disease

  01/11/2022-01/05/2024

Other Outcomes (1)

• Raman spectrum classification

  11/05/2023-20/06/2024

Study Arms (4)

CHD + CHF

Coronary Heart Disease with overt Chronic Heart Failure (200 participants)

Diagnostic Test: surface enhanced Raman Spectroscopy

CHD

Coronary Heart Disease without Chronic Heart Failure (70 participants)

Diagnostic Test: surface enhanced Raman Spectroscopy

NICMP +CHF

Non-Ischemic Cardiomyopathies with overt Chronic Heart Failure (50 participants)

Diagnostic Test: surface enhanced Raman Spectroscopy

VCMP+CHF

Valvular Cardiomyopathies with overt Chronic Heart Failure (40 participants)

Diagnostic Test: surface enhanced Raman Spectroscopy

Interventions

surface enhanced Raman Spectroscopy DIAGNOSTIC_TEST

Spectral measurements of blood serum were performed on a silver nanoparticle substrate. Each 1.5 μL serum sample was applied to a substrate with a layer of silver nanoparticles and dried . The spectral characteristics of serum were analyzed using an experimental bench consisting of a spectrometric system and a microscope . The spectra were excited by laser module with a center wavelength of 785 nm. Each of the obtained spectra was a discrete set of 1700 parameters . For skin Raman spectroscopy an experimental portable RS system was used, including a 785 nm diode laser , a portable commercially available Raman probe to filter the collected scattered radiation, and a portable spectrometer (QE65Pro, Ocean optics, Florida, USA). The scattered radiation was collected from the upper 1 to 2 mm thick skin layer. The Raman spectral range was 780-1000 nm with resolution of 0.2 nm. Each spectrum was recorded at an exposure time of 20 seconds with three-fold accumulation.

Also known as: Skin Raman Spectroscopy

CHD; CHD + CHF; NICMP +CHF; VCMP+CHF

Eligibility Criteria

• Age: 35 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The researchers included participants from among those hospitalized in the cardiology department of an urban acute care hospital (groups 1,3,4)because of first-diagnosed chronic heart failure or its exacerbation. Group 2 consisted of patients with clinically and instrumentally proven chronic ischemic heart disease without manifestations of CHF also hospitalized. Reasons for hospitalization in this group were related to BP elevation, paroxysms of atrial fibrillation/atrial flutter. Selection into the study was made among consecutively admitted patients, provided that the inclusion criteria were met

You may qualify if:

• Group 1(CHD+CHF): clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels. Any form of Coronary Heart Disease :angina pectoris up to and including 2 functional class, previous myocardial infarction, percutaneous coronary intervention or coronary arteries bypass grafts. possible functional insufficiency of A-V valves, arterial hypertension, possibly with chronic atrial fibrillation/atrial fibrillation of any form, ventricular extrasystoles of any class, Hiss bundle branch block not requiring implantation of devices, ability to self-care.
• Group 2(CHD): Any form of Cronic Heart Disease :angina pectoris up to and including 2 functional class, previous myocardial infarction, percutaneous coronary intervention or coronary arteries bypass grafts, possible functional insufficiency of A-V valves of 1 stage, arterial hypertension, possibly with chronic atrial fibrillation/ flatter of any form, ventricular extrasystoles of any class, Hiss bundle branch block not requiring implantation of devices, ability to self-care.
• Group 3 (NICMPs+CHF): clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels without signs of CHD in the history, without violation of coronary anatomy - stenoses (MSCT and coronary angiography). Possible functional insufficiency of A-B valves of the 1st degree, arterial hypertension, possible chronic forms of atrial fibrillation/ flatter, ventricular extrasystoles of any class, blockade of the Hiss legs not requiring implantation of devices, capable of self-care.
• Group 4 (VCMPs+CHF):Valvular acquared cardiomyopathies with clinically evident CHF II-IV NYHA Classes,confirmed by NT-proBNP diagnostic levels without signs of CHD in the history, without violation of coronary anatomy - stenoses (MSCT and coronary angiography). Possible functional insufficiency of A-B valves of the 1st degree, arterial hypertension, possible chronic forms of atrial fibrillation/ flatter, ventricular extrasystoles of any class, blockade of the Hiss legs not requiring implantation of devices, capable of self-care.

Sponsors & Collaborators

• Samara State Medical University: lead
• City Clinical Hospital No.1 named after N.I. Pirogov: collaborator

Study Sites (1)

city Samara hospital n.a. N.I.Pirogov

Samara, 443099, Russia

Location

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.
• 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

Retention: SAMPLES WITHOUT DNA

2 ml of blood serum from each participant for Raman spectroscopy were collected and processed. All other biochemical analysis were provided by hospital central laboratory

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Petr A Lebedev, professor

  chief of therapy chair of professional education department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: November 1, 2022
• Primary Completion: October 11, 2024
• Study Completion: November 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)