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

NCT ID: NCT02779127

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-06-30

Brief 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.

Conditions

Smoking

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Medical interrogatory

Intervention Type: OTHER

Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated

Medical examination

Intervention Type: OTHER

Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation

Specific bioassay

Intervention Type: OTHER

Exhaled carbon monoxide measure and nicotine in the urine are evaluated

Endothelial function evaluation

Intervention Type: OTHER

Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation

General bioassay

Intervention Type: OTHER

Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.

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

Group Type: OTHER

Medical interrogatory

Intervention Type: OTHER

Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated

Medical examination

Intervention Type: OTHER

Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation

Specific bioassay

Intervention Type: OTHER

Exhaled carbon monoxide measure and nicotine in the urine are evaluated

Endothelial function evaluation

Intervention Type: OTHER

Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation

General bioassay

Intervention Type: OTHER

Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.

Interventions

Medical interrogatory

Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated

Intervention Type: OTHER

Medical examination

Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation

Intervention Type: OTHER

Specific bioassay

Exhaled carbon monoxide measure and nicotine in the urine are evaluated

Intervention Type: OTHER

Endothelial function evaluation

Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation

Intervention Type: OTHER

General bioassay

Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandra BURA-RIVIERE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Other Identifiers

07 269 03

Identifier Type: -

Identifier Source: org_study_id