Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers (NCT02779127) | Clinical Trial Compass
CompletedNot Applicable
Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers
France49 participantsStarted 2007-12-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.