Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers : Evaluation of Endothelial Vasomotoricity Before and After Cessation of Exposure to Passive Smoking : DILATER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Comparison of Endothelial function between two groups of non smoking workers exposed or not to passive smoking at work before and after interdiction of smoking decree as assessed by mean change in dilatation percentage of brachial artery.
研究概览
简要总结
Endothelium is considered a real member, so it is contributing to determine the vascular homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by non-invasive study of the variation of gauge of the brachial artery as a result of post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events. Several recent studies have shown that passive smoking is correlated with endothelial dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to smoking in non-smoking subjects, as part of a prospective study and controlled, has never been evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject exposed at least one hour per day to passive smoking at work during at 1 year minimum for intervention arm and non exposed to passive smoking for control group.
- •Subject having signed informed consent
- •Subject with social security insurance or equivalent
排除标准
- •Exposition to passive smoking at home
- •Active smokers (at least 1 cigarette per day or having drawn up active smoking for less than a month)
- •Medical history of homozygote familial hypercholesterolemia
- •Usage of lipid lowering treatment in the month before the inclusion
- •Hepatic active pathology or hepatocellular insufficiency
- •Severe kidney disease (with creatine clearance less than 30 ml per minute)
- •Evolutive cancer
- •Usage of concomitant treatment as : insulin, nitro-derivatives and statins
- •Medical history of alcoholism or drug use last year
- •Medical history of permanent systolic hypotension (systolic blood pressure less than 90 mmHg) or non controled hypertension (systolic blood pressure higher than 200 mmHg and diastolic blood pressure 110 mmHg)
- •Active cardiovascular disease
- •Psychological or medical conditions incompatible with the study according to investigator opinion
- •Participation to another study with experimental product or subject having received an study treatment within 4 weeks before inclusion
- •Impossibility to follow the study procedure
- •Pregnancy and breastfeeding
- •Subject protected by french law
研究组 & 干预措施
Intervention
Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Medical interrogatory (Other)
Intervention
Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Medical examination (Other)
Intervention
Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Specific bioassay (Other)
Intervention
Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Endothelial function evaluation (Other)
Intervention
Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: General bioassay (Other)
Control
Subjects non expose to passive smoking at home or at work, non active smokers
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Medical interrogatory (Other)
Control
Subjects non expose to passive smoking at home or at work, non active smokers
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Medical examination (Other)
Control
Subjects non expose to passive smoking at home or at work, non active smokers
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Specific bioassay (Other)
Control
Subjects non expose to passive smoking at home or at work, non active smokers
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: Endothelial function evaluation (Other)
Control
Subjects non expose to passive smoking at home or at work, non active smokers
Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
干预措施: General bioassay (Other)
结局指标
主要结局
Comparison of Endothelial function between two groups of non smoking workers exposed or not to passive smoking at work before and after interdiction of smoking decree as assessed by mean change in dilatation percentage of brachial artery.
时间窗: change between Day 0 and Day 90
Percentage of dilation of the brachial artery after test ischemia will be compared at the start and at the end of the study (Day 90)
次要结局
- Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.(change between Day 0 and Day 90)