Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers (DILATER)

Toulouse University Hospital

Status: Completed

Conditions: Smoking

Treatments: Other: Endothelial function evaluation; Other: Specific bioassay; Other: General bioassay; Other: Medical examination; Other: Medical interrogatory

Study type: Interventional

Funder types: Other

Identifiers

NCT02779127

07 269 03

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

Intervention

Other group

Description:

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

Treatment:

Other: General bioassay

Other: Endothelial function evaluation

Other: Specific bioassay

Other: Medical interrogatory

Other: Medical examination

Control

Other group

Description:

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

Treatment:

Other: General bioassay

Other: Endothelial function evaluation

Other: Specific bioassay

Other: Medical interrogatory

Other: Medical examination