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Cardiovascular Comorbidities and Bronchiectasis (BRONCOCA)

This study is currently recruiting participants.
Verified July 2017 by Bernard MAITRE, Centre Hospitalier Intercommunal Creteil
Sponsor:
ClinicalTrials.gov Identifier:
NCT02804971
First Posted: June 17, 2016
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bernard MAITRE, Centre Hospitalier Intercommunal Creteil
  Purpose

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
Bronchiectasis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

Further study details as provided by Bernard MAITRE, Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • 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:
  • 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. ]
  • 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. ]
  • 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. ]

Estimated Enrollment: 200
Actual Study Start Date: September 2016
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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
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
Contact: Bernard MAITRE, MD PhD 1 57 02 21 17 ext +33 bm.maitre@gmail.com

Locations
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
Principal Investigator: Bernard MAITRE CHI Créteil
  More Information

Responsible Party: Bernard MAITRE, Pr, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02804971     History of Changes
Other Study ID Numbers: BRONCOCA
First Submitted: June 15, 2016
First Posted: June 17, 2016
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases