Relationship Between Cardiovascular Disease in Asthma and Eosinophil Subtypes and Biomarkers of Bronchial Remodeling.

October 18, 2022 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Recent studies have shown that asthma could be a risk factor for cardiovascular disease, especially in the female and late-onset subgroups. The two entities share several risk factors, such as chronic inflammation and bronchial remodeling. Eosinophilia, characteristic of asthma, has also been described as a predictor of cardiovascular mortality.

The aim of this study is to determine the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthmatic patients with and without cardiovascular disease

Description

Inclusion Criteria:

  • Previous diagnosis of asthma
  • Signed informed consent

Exclusion Criteria:

  • Age under 18 years old
  • Age over 99 years old
  • Pneumological diseases other than asthma
  • Active oncological diseases or with end of treatment <5 years
  • Autoimmune or systemic inflammatory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
With cardiovascular disease
Asthma patients with cardiovascular disease
Other: Asthma and cardiovascular disease
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.
Without cardiovascular disease
Asthma patients without cardiovascular disease
Other: Asthma and cardiovascular disease
To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease, as well as their relationship with eosinophil subtypes, biomarkers of chronic inflammation and bronchial remodeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of patients with asthma
Time Frame: 1 year
Spirometry with bronchodilator testing
1 year
Associated cardiovascular disease type
Time Frame: 1 year
Cardiac infarction, stroke or peripheral artery disease
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eosinophil subtypes
Time Frame: 1 year
Eosinophil subtypes of patients with asthma and cardiovascular disease
1 year
Biomarkers of chronic inflammation
Time Frame: 1 year
Transforming growth factor-β, interleukin-5, interleukin-13, interleukin-25 and interleukin-3
1 year
Bronchial remodeling
Time Frame: 1 year
Bronchial remodeling of patients with asthma and cardiovascular disease measured by analysis of images obtained by thoracic CT scanning
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-ASM-2022-89

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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