NCT01195064终止不适用
Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients
University Hospital, Grenoble3 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2010年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 109
- 试验地点
- 3
- 主要终点
- The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.
研究概览
简要总结
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.
An interim analysis will be performed when 100 patients will be included.
详细描述
Secondary objectives of this clinical trial :
- To evaluate the effect of COPD and/or OSAS on the systemic inflammation, insulin-resistance and oxydative stress, in comparison with non COPD non OSAS patients.
- To evaluate the effect of COPD and/or OSAS on the inflammation and oxydative stress of the adipose tissue, in comparison with non COPD non OSAS patients.
- To validate the STOP-BANG questionnaire in patients undergoing a cardiovascular surgery
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between 18 and 80 years old
- •Patient with planned coronary artery bypass graft surgery
- •Patient with planned peripheral vascular surgery
- •Patient with aortic surgery
排除标准
- •Patient with aortic or mitral valvular replacement
- •Patient with emergency peripheral valvular surgery
- •Patient with emergency coronary artery bypass graft surgery
- •Patient with evolutive malignancy disease
- •Pregnant or lactating women
- •Patient with inadvisable bronchodilator (used for functional respiratory) exploration
结局指标
主要结局
The primary endpoint is the percent of peripheral arterial tone (PAT) in COPD and/or OSAS patients compared to non COPD non OSAS patients.
时间窗: one week before their cardiovascular surgery
次要结局
- Polysomnography(one week before their cardiovascular surgery)
- Evaluation of the systemic inflammation, insulin-resistance and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.(one week before their cardiovascular surgery)
- Evaluation of adipose tissue inflammation and oxidative stress occurring during COPD and/or OSAS patients compared to non COPD non OSAS patients.(one week before their cardiovascular surgery)
- Functional respiratory exploration(one week before their cardiovascular surgery)
研究者
研究点 (3)
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