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临床试验/NCT02804971
NCT02804971已完成不适用

Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

Centre Hospitalier Intercommunal Creteil2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Frequency of the cardiovascular comorbidities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Frequency of the cardiovascular comorbidities

时间窗: Examinations / tests required for this primary outcome measure will be performed within the month following the inclusion visit.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Bernard MAITRE

Pr

Centre Hospitalier Intercommunal Creteil

研究点 (2)

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