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

NCT02779127 | Completed

• 1 other identifier: 07 269 03
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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

Keywords

Smoking; Endothelium; Passive smoking

Outcome Measures

Primary Outcomes (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.

  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)

  change between Day 0 and Day 90

Secondary Outcomes (1)

• 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

Study Arms (2)

Intervention

OTHER

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

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

Control

OTHER

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

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

Interventions

Medical interrogatory OTHER

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

Control; Intervention

Medical examination OTHER

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

Control; Intervention

Specific bioassay OTHER

Exhaled carbon monoxide measure and nicotine in the urine are evaluated

Control; Intervention

Endothelial function evaluation OTHER

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

Control; Intervention

General bioassay 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; Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Impossibility to follow the study procedure
• Pregnancy and breastfeeding
• Subject protected by french law

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Smoking

Interventions

Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Alessandra BURA-RIVIERE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: May 20, 2016
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share