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

NCT06393595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-12-27

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

surface enhanced Raman Spectroscopy

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.

Sponsors & Collaborators

  • City Clinical Hospital No.1 named after N.I. Pirogov

    collaborator OTHER
  • Samara State Medical University

    lead OTHER

Principal Investigators

  • Petr A Lebedev, professor · chief of therapy chair of professional education department

Eligibility

Min Age
35 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-10-11
Completion
2024-11-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06393595 on ClinicalTrials.gov