Cardiovascular Comorbidities and Bronchiectasis (BRONCOCA)

Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Natural history is marked by recurrent infectious diseases which are the main prognosis factor. This disease is associated with an inflammation rate in the lung as well as in the blood. Up to now, no study has been described comorbidities associated with this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent in these patients. In fact systemic inflammation driven by bronchial infections may increase frequency of cardiovascular diseases.

The investigators decide to conduct a monocentric observational study to define the prevalence and characterization of cardiovascular comorbidities as well as markers of accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are frequent in bronchiectasis and may be associated with markers of inflammation and aging.

Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.

Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.

Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.

Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchiectasis

Detailed Description

Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.

Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.

Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.

Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • CHI Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of bronchiectasis based on imaging in a recent (less than 2 years) CT-scan.

Description

Inclusion Criteria:

• 40 ≤ Age ≤ 80 years
• Formal diagnosis of bronchiectasis by imaging (CT-scan)
• For women, pregnancy test negative
• Affiliation to a social Security
• written inform consent

Exclusion Criteria:

• Patients with a diagnosis of Cystic Fibrosis
• Contre indication of one of the tests
• Exacerbation with hospitalization or outpatient clinic visit in the last 4 weeks.
• Unability to obtain an informed consent
• Pregnancy or Breast feeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of the cardiovascular comorbidities	Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of aging-related abnormalities (higher aortic pulse-wave velocity, lower bone mineral density, lower squelettal muscle mass index) and shorter telomere length in patients.	Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Correlation between the severity of the disease (BSI score) and cardiovascular comorbidities.	Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.
Correlation between biological markers of aging and inflammation.	Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Bernard MAITRE, CHI Créteil

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2016
• Primary Completion (Actual): October 25, 2021
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimated): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: BRONCOCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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