Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)

Ryazan State Medical University476 enrolled

Overview

one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis

Risk factors, chronic respiratory symptoms and respiratory function in the natural history of COPD will be monitored. In a group of patients with a comorbid course of COPD and atherosclerosis, systemic inflammation and its molecular mechanisms will be investigated. Also in this group, the role of non-coding miRNAs will be analyzed. The study also includes an analysis of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

476

Conditions

Chronic Obstructive Pulmonary Disease Peripheral Artery Disease

Interventions

Breath Condensate CollectionDIAGNOSTIC_TEST

Breath Condensate Collection

clinical examination, spirometryDIAGNOSTIC_TEST

spirometry

blood monocyte assayDIAGNOSTIC_TEST

study of blood monocytes in the laboratory of cell technology

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation. 2. A significant diagnosis of peripheral atherosclerosis 3. The high level of adherence to treatment 4. Signed informed agreement Exclusion Criteria: 1. The presence of other chronic respiratory diseases in the patient, including bronchial asthma 2. Known oncological diseases of any localization 3. HIV infection and other immunodeficiency conditions 4. Inability to understand and comply with the requirements of the research protocol.

Locations (1)

Ryazan State Medical University

Ryazan, Please Select, Russia

Outcomes

Primary Outcomes

mortality

the number of deaths from cardiovascular causes

Time frame: 12 months

lung function

progression of decreased lung function (FEV1%) according to spirometry

Time frame: 12 months

exacerbations

frequency of exacerbations of COPD (number of cases per year)

Time frame: 12 months

markers of inflammation

biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)

Time frame: 12 months

Data from ClinicalTrials.gov

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