Skip to main content
OpenTrials
Completed

NCT Number: NCT04474717

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryazan State Medical University

Ryazan, Please Select, 390005, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation.
  • A significant diagnosis of peripheral atherosclerosis
  • The high level of adherence to treatment
  • Signed informed agreement

Exclusion criteria

  • The presence of other chronic respiratory diseases in the patient, including bronchial asthma
  • Known oncological diseases of any localization
  • HIV infection and other immunodeficiency conditions
  • Inability to understand and comply with the requirements of the research protocol.

Treatment and study plan

Breath Condensate Collection

Diagnostic Test

Breath Condensate Collection

clinical examination, spirometry

Diagnostic Test

spirometry

blood monocyte assay

Diagnostic Test

study of blood monocytes in the laboratory of cell technology

Primary outcomes

  1. mortality

    Time frame: 12 months

    the number of deaths from cardiovascular causes

  2. lung function

    Time frame: 12 months

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

  3. exacerbations

    Time frame: 12 months

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

  4. markers of inflammation

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Official study title

Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.