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

NCT ID: NCT04474717

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2023-07-19

Brief Summary

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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

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Peripheral Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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The natural history of COPD

Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease

Group Type OTHER

clinical examination, spirometry

Intervention Type DIAGNOSTIC_TEST

spirometry

Study of systemic inflammation and molecular mechanisms

Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis

Group Type EXPERIMENTAL

blood monocyte assay

Intervention Type DIAGNOSTIC_TEST

study of blood monocytes in the laboratory of cell technology

Exhaled breath condensate

A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity

Group Type OTHER

Breath Condensate Collection

Intervention Type DIAGNOSTIC_TEST

Breath Condensate Collection

Interventions

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Breath Condensate Collection

Breath Condensate Collection

Intervention Type DIAGNOSTIC_TEST

clinical examination, spirometry

spirometry

Intervention Type DIAGNOSTIC_TEST

blood monocyte assay

study of blood monocytes in the laboratory of cell technology

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ryazan State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ryazan State Medical University

Ryazan, Please Select, Russia

Site Status

Countries

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Russia

Other Identifiers

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15.06.2020

Identifier Type: -

Identifier Source: org_study_id

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