Prediction of Outcomes in Patients With Chronic Heart Failure Based on Tissue Raman Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- record in electronic medical information analitical system(EMIAS)
研究概览
简要总结
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.
详细描述
This study included participants hospitalized in the cardiology unit of Samara city Clinical Hospital No.1 n.a. N.I.Pirogov of Emergency Medical Aid.The 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.
2)To 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:
- Group with CHF based on CHD of both sexes aged 35 to 84 years (200 participants);
- Group with CHD without CHF (70 participants);
- Group with CHF with non-ischemic cardiomyopathies (50 participants);
- group with CHF and valvular cardiomyopathies (40 participants)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Exclusion criteria (for groups 1-4): Acute myocardial infarction or unstable angina within the last 6 months, Dementia, lack of signed consent, CKD 4st or higher, tuberculosis, active cancer, liver cirrhosis of infectious etiology, chronic anemia : Hemoglobin less than 95 g/L, inability to self-care, type 1 diabetes mellitus,or insulin-dependent type 2 DM , anticipated heart valve surgery within one year, uncontrolled endocrine disease or malignancy likely to affect prognosis.
结局指标
主要结局
record in electronic medical information analitical system(EMIAS)
时间窗: 01.11.2022-01.05.2024
The initial information of participant's death would be verified by official record
record in electronic medical information analitical system (EMIAS)
时间窗: 01/11/2022-01/05/2024
The initial information of participant's cardiovascular death would be verified by official record
次要结局
- record in electronic medical information analitical system (EMIAS) and history of disease(01/11/2022-01/05/2024)