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Trial record 1 of 1 for:    NCT02804971
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Cardiovascular Comorbidities and Bronchiectasis (BRONCOCA)

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ClinicalTrials.gov Identifier: NCT02804971
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Bernard MAITRE, Centre Hospitalier Intercommunal Creteil

Study Description
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Brief Summary:

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.


Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Frequency of the cardiovascular comorbidities [ Time Frame: Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit. ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit. ]
  2. Correlation between the severity of the disease (BSI score) and cardiovascular comorbidities. [ Time Frame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit. ]
  3. Correlation between biological markers of aging and inflammation. [ Time Frame: Examinations / tests required for this secondary outcome measure will be performed within the month following the inclusion visit. ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804971


Contacts
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Contact: Bernard MAITRE, MD PhD 1 57 02 21 17 ext +33 bm.maitre@gmail.com

Locations
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France
Chi Creteil Recruiting
Créteil, France, 94000
Contact: Camille JUNG, MD PhD         
Principal Investigator: Laurence BASSINET, MD         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Investigators
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Principal Investigator: Bernard MAITRE CHI Créteil
More Information
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Responsible Party: Bernard MAITRE, Pr, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02804971    
Other Study ID Numbers: BRONCOCA
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases