Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of the pulse wave velocity (PWV)
研究概览
简要总结
The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.
详细描述
Reduced lung function is a major risk factor for cardiovascular mortality (CV), regardless of age, sex and history of smoking. Similarly, CV events are known causes of mortality in patients with chronic obstructive pulmonary disease (COPD). The investigators propose to determine the parameters influencing the evolution of CV risk in a cohort of COPD patients followed over 5 years. For this the investigators will study the role of inflammation, oxidative stress, and vascular, respiratory and peripheral muscle function parameters.
In order to study a sufficient number of patients the investigators propose to group data from two cohorts: a first cohort of 121 COPD patients that already exists (currently closed to inclusions but still undergoing follow-up (NCT00404430)) and a new cohort of 150, decompensated or not, COPD patients.
This study is of major scientific interest and will enable to obtain extremely important information to better understand COPD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients with stable COPD:
- •Men or women aged 18 to 85
- •FEV1/FVC < 70% or proven BPCO
- •Patients who have given their free and informed consent in writing
- •For patients with decompensated COPD:
- •Men or women aged 18 to 85
- •FEV1/FVC < 70% or proven BPCO
- •At the time of acute respiratory failure (ARF), when admitted to hospital:
- •Respiratory rate > 25 cycles per minute
- •PaCO2 > 45 mmHg
- •blood pH < 7.35
- •When included in the study:
- •pH > 7.33 at the end of ARF, 2 days in a row, or 3 to 7 days post-D1 decompensation (admission to the hospital)
- •Fever < 38.5°C
- •Patients who have given their free and informed consent in writing
排除标准
- •Obvious evolving infection or CRP > 100 mg/L
- •Cardiac decompensation considered the main cause of decompensation or chronic heart failure with LVEF < 45%
- •Evolving neoplasia
- •On antioxidants: N-acetyl-cysteine, selenium, vit. C, vit. E
- •Pregnant or nursing women
- •Patients under tutorship or curatorship
- •Patients participating in a drug clinical research study
- •Patients not affiliated to the French social security system (or equivalent)
- •Patients deprived of liberty or hospitalized without consent.
结局指标
主要结局
Change of the pulse wave velocity (PWV)
时间窗: During 5 years since inclusion (once a year)
Measurement of pulse wave velocity (PWV), which reflects cardiovascular risk (CVR). This measure will be performed at each visit (V1, V1 bis, V2, V3, V4, V5 and V6).
次要结局
- Correlations between the parameters of severity of pulmonary disease and physical activity.(During 5 years since inclusion (once a year))
- Monitoring of COPD exacerbations compared to evolution of PWV(During 5 years since inclusion)
- Prevalence of nocturnal "non-dipping" of blood pressure during COPD.(During 5 years since inclusion (once a year))
- Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD.(At inclusion visit)
- Relationship between the new cardiovascular (CV) events and the evolution of the PWV.(During 5 years since inclusion (once a year))