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NCT05589779 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05589779
Other study ID # IIBSP-ASM-2022-89
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date August 1, 2024

Study information
Verified date October 2022
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Esther Palones, MD
Phone +34 93 556 56 01
Email epalones@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To know the clinical and inflammatory characteristics of patients with asthma and associated cardiovascular disease.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date August 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

References & Publications (13)

Banno A, Reddy AT, Lakshmi SP, Reddy RC. Bidirectional interaction of airway epithelial remodeling and inflammation in asthma. Clin Sci (Lond). 2020 May 15;134(9):1063-1079. doi: 10.1042/CS20191309. Review. — View Citation

Guite HF, Dundas R, Burney PG. Risk factors for death from asthma, chronic obstructive pulmonary disease, and cardiovascular disease after a hospital admission for asthma. Thorax. 1999 Apr;54(4):301-7. — View Citation

Januskevicius A, Jurkeviciute E, Janulaityte I, Kalinauskaite-Zukauske V, Miliauskas S, Malakauskas K. Blood Eosinophils Subtypes and Their Survivability in Asthma Patients. Cells. 2020 May 18;9(5). pii: E1248. doi: 10.3390/cells9051248. — View Citation

Kannel WB, Hubert H, Lew EA. Vital capacity as a predictor of cardiovascular disease: the Framingham study. Am Heart J. 1983 Feb;105(2):311-5. — View Citation

Lee HM, Liu MA, Barrett-Connor E, Wong ND. Association of lung function with coronary heart disease and cardiovascular disease outcomes in elderly: the Rancho Bernardo study. Respir Med. 2014 Dec;108(12):1779-85. doi: 10.1016/j.rmed.2014.09.016. Epub 2014 — View Citation

Liu H, Fu Y, Wang K. Asthma and risk of coronary heart disease: A meta-analysis of cohort studies. Ann Allergy Asthma Immunol. 2017 Jun;118(6):689-695. doi: 10.1016/j.anai.2017.03.012. Epub 2017 Apr 19. — View Citation

Mesnil C, Raulier S, Paulissen G, Xiao X, Birrell MA, Pirottin D, Janss T, Starkl P, Ramery E, Henket M, Schleich FN, Radermecker M, Thielemans K, Gillet L, Thiry M, Belvisi MG, Louis R, Desmet C, Marichal T, Bureau F. Lung-resident eosinophils represent — View Citation

Rothenberg ME, Hogan SP. The eosinophil. Annu Rev Immunol. 2006;24:147-74. Review. — View Citation

Schroeder EB, Welch VL, Couper D, Nieto FJ, Liao D, Rosamond WD, Heiss G. Lung function and incident coronary heart disease: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2003 Dec 15;158(12):1171-81. — View Citation

Sin DD, Wu L, Man SF. The relationship between reduced lung function and cardiovascular mortality: a population-based study and a systematic review of the literature. Chest. 2005 Jun;127(6):1952-9. Review. — View Citation

Wang L, Gao S, Yu M, Sheng Z, Tan W. Association of asthma with coronary heart disease: A meta analysis of 11 trials. PLoS One. 2017 Jun 13;12(6):e0179335. doi: 10.1371/journal.pone.0179335. eCollection 2017. — View Citation

Xu M, Xu J, Yang X. Asthma and risk of cardiovascular disease or all-cause mortality: a meta-analysis. Ann Saudi Med. 2017 Mar-Apr;37(2):99-105. doi: 10.5144/0256-4947.2017.99. Review. — View Citation

Zhang B, Li ZF, An ZY, Zhang L, Wang JY, Hao MD, Jin YJ, Li D, Song AJ, Ren Q, Chen WB. Association Between Asthma and All-Cause Mortality and Cardiovascular Disease Morbidity and Mortality: A Meta-Analysis of Cohort Studies. Front Cardiovasc Med. 2022 Ma — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical characteristics of patients with asthma Spirometry with bronchodilator testing 1 year
Primary Associated cardiovascular disease type Cardiac infarction, stroke or peripheral artery disease 1 year
Secondary Eosinophil subtypes Eosinophil subtypes of patients with asthma and cardiovascular disease 1 year
Secondary Biomarkers of chronic inflammation Transforming growth factor-ß, interleukin-5, interleukin-13, interleukin-25 and interleukin-3 1 year
Secondary Bronchial remodeling Bronchial remodeling of patients with asthma and cardiovascular disease measured by analysis of images obtained by thoracic CT scanning 1 year
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